RESUMEN
BACKGROUND: Decision-making processes have been posited to affect treatment outcome in addicted patients. OBJECTIVE: The present multi-site study assessed whether two measures of decision-making predicted relapse and subsequent use in stimulant-dependent patients. METHODS: A total of 160 methamphetamine- or cocaine-dependent patients participating in a multi-site clinical trial evaluating a modified 12-step facilitation intervention for stimulant-dependent patients (STAGE-12) were assessed. Decision-making processes of risk and delay (Iowa Gambling Task [IGT]) and response reversal (Wisconsin Card Sorting Task [WCST]) were obtained shortly after treatment admission followed by assessment of stimulant use over the next six months. The relationships of the IGT and WCST (Perseverative Errors) with relapse (yes/no) and days of stimulant use during the 6-month period following post-randomization were evaluated. RESULTS: Performance on the IGT and WCST did not significantly predict relapse status or time to relapse. Unexpectedly, worse performance on the IGT was associated with a fewer number of stimulant use days (p = 0.001). In contrast, worse performance on the WCST (more perseverative errors) was associated with a greater number of stimulant use days (p = 0.0003). The predictive effects of perseverative errors on subsequent use were confined to methamphetamine-dependent and Minority participants. CONCLUSIONS: Decision-making processes, as measured in the current study, do not uniformly predict relapse or subsequent use. A decrease in the salience attribution of non-drug reinforcers may explain the positive relationship between IGT performance and post-relapse use. More comprehensive and global measures of impulsiveness may better assess relapse risk and use.
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Trastornos Relacionados con Anfetaminas/psicología , Trastornos Relacionados con Cocaína/psicología , Toma de Decisiones , Valor Predictivo de las Pruebas , Adulto , Femenino , Humanos , Masculino , Pruebas Neuropsicológicas , Recurrencia , Factores de Tiempo , Adulto JovenRESUMEN
We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions. Alliance was not related to substance use outcomes. Implications and limitations of the findings are discussed.
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National Institute on Drug Abuse (U.S.) , Evaluación de Resultado en la Atención de Salud/métodos , Cooperación del Paciente , Trastornos por Estrés Postraumático/terapia , Adolescente , Adulto , Anciano , Atención Ambulatoria , Femenino , Humanos , Persona de Mediana Edad , Centros de Tratamiento de Abuso de Sustancias , Trastornos Relacionados con Sustancias/terapia , Encuestas y Cuestionarios , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings. OBJECTIVES: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners. METHODS: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each. RESULTS: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability. CONCLUSION: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN. SCIENTIFIC SIGNIFICANCE: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.
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Protocolos Clínicos , Servicios de Salud Comunitaria/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Trastornos Relacionados con Sustancias/rehabilitación , Conducta Cooperativa , Toma de Decisiones , Humanos , National Institute on Drug Abuse (U.S.) , Proyectos de Investigación , Grupos de Autoayuda/organización & administración , Estados UnidosRESUMEN
The U.S. Federal Food and Drug Administration approved buprenorphine for drug abuse treatment in 2002, and it became available for clinical use in early 2003. Maryhaven, a community treatment program, participated in a National Institute on Drug Abuse Clinical Trials Network trial evaluating buprenorphine-naloxone (BNX; Suboxone) short-term taper for medically managed opioid withdrawal and later adopted this treatment. In a retrospective review, the first 64 patients treated with a BNX taper were compared with two groups of patients treated with clonidine before and after the implementation of the BNX program. Significantly more patients (about 80%) receiving BNX continued in further treatment compared to about 30% of those receiving clonidine. Patient outcomes are discussed in the context of the critical need for treatment continuation following detoxification. Common questions of potential adopters of the BNX taper are presented and addressed. Overall, BNX was readily integrated into the existing treatment service.
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Analgésicos Opioides/administración & dosificación , Buprenorfina/administración & dosificación , Trastornos Relacionados con Opioides/rehabilitación , Aceptación de la Atención de Salud , Síndrome de Abstinencia a Sustancias/prevención & control , Adulto , Analgésicos/uso terapéutico , Análisis de Varianza , Clonidina/uso terapéutico , Esquema de Medicación , Femenino , Humanos , Masculino , Ohio , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Estudios RetrospectivosRESUMEN
Smoking is the leading cause of preventable death in the United States. This public health problem is of particular concern among individuals with substance use disorders in that they smoke at a greater rate than the general public. Smoking-related illness represents a major source of preventable death in persons with drug dependencies. Substance abuse treatment programs have access to persons with substance use disorders and the opportunity to intervene on their smoking; however, nicotine dependence has historically not been viewed in the same light as other drug dependencies by the treatment field. As a result, many persons in these treatment program settings do not receive opportunities to address their smoking. When substance abuse treatment organizations consider implementing smoking policies and services, many questions and choices arise. In practice, a range of approaches has been developed from simple assessment and referral for smoking cessation treatment to implementing smoke-free grounds and requiring that patients stop smoking concurrent with addressing their other drug dependencies. Smoking cessation policy decisions have the potential to directly affect the patients, the workforce, the referral network, and other major stakeholders related to these organizations. The authors consider a range of both practical and policy issues facing treatment organizations and conclude that advances in smoking policy are possible with current resources.
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Centros Comunitarios de Salud Mental/organización & administración , Política Organizacional , Fumar , Trastornos Relacionados con Sustancias/rehabilitación , Humanos , Cese del Hábito de FumarRESUMEN
Although substance abuse professionals are generally open to new and better therapeutic methods, most evidence-based treatments do not easily find their way into practice. Natural diffusion processes for innovations in substance abuse treatments are relatively informal and have yielded a widely acknowledged gap between science and community practice. This review focuses on methods for effectively disseminating new treatment methods into practice. Therapist manuals and one-time workshops are in themselves relatively ineffective in helping practitioners gain proficiency in new clinical approaches. Individual performance feedback and coaching improve the acquisition of clinical skills. Specific incentives for implementation may also be needed to encourage treatment providers, programs, and systems to adopt new approaches.
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Medicina Basada en la Evidencia , Trastornos Relacionados con Sustancias/rehabilitación , Terapia Conductista , Ensayos Clínicos como Asunto , Comunicación , Difusión de Innovaciones , Planificación en Salud , Humanos , Estados UnidosRESUMEN
OBJECTIVE: Few studies have examined the effectiveness of 12-step peer recovery support programs with drug use disorders, especially stimulant use, and it is difficult to know how outcomes related to 12-step attendance and participation generalize to individuals with non-alcohol substance use disorders (SUDs). METHOD: A clinical trial of 12-step facilitation (N=471) focusing on individuals with cocaine or methamphetamine use disorders allowed examination of four questions: Q1) To what extent do treatment-seeking stimulant users use 12-step programs and, which ones? Q2) Do factors previously found to predict 12-step participation among those with alcohol use disorders also predict participation among stimulant users? Q3) What specific baseline "12-step readiness" factors predict subsequent 12-step participation and attendance? And Q4) Does stimulant drug of choice differentially predict 12-step participation and attendance? RESULTS: The four outcomes variables, attendance, speaking, duties at 12-step meetings, and other peer recovery support activities, were not related to baseline demographic or substance problem history or severity. Drug of choice was associated with differential days of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) attendance among those who reported attending, and cocaine users reported more days of attending AA or NA at 1-, 3- and 6-month follow-ups than did methamphetamine users. Pre-randomization measures of perceived benefit of 12-step groups predicted 12-step attendance at 3- and 6-month follow-ups. Pre-randomization 12-step attendance significantly predicted number of other self-help activities at end-of-treatment, 3- and 6-month follow-ups. Pre-randomization perceived benefit and problem severity both predicted number of self-help activities at end-of-treatment and 3-month follow-up. Pre-randomization perceived barriers to 12-step groups were negatively associated with self-help activities at end-of-treatment and 3-month follow-up. Whether or not one participated in any duties was predicted at all time points by pre-randomization involvement in self-help activities. CONCLUSIONS: The primary finding of this study is one of continuity: prior attendance and active involvement with 12-step programs were the main signs pointing to future involvement. Limitations and recommendations are discussed.
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Trastornos Relacionados con Anfetaminas/rehabilitación , Trastornos Relacionados con Cocaína/rehabilitación , Grupos de Autoayuda , Trastornos Relacionados con Sustancias/rehabilitación , Alcohólicos Anónimos , Estimulantes del Sistema Nervioso Central/administración & dosificación , Estimulantes del Sistema Nervioso Central/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Metanfetamina/administración & dosificación , Metanfetamina/efectos adversos , Aceptación de la Atención de Salud , Factores de TiempoRESUMEN
INTRODUCTION: For opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized. This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies. METHODS: The National Institute on Drug Abuse's Clinical Trials Network (CTN) study CTN-0051, X:BOT, is a comparative effectiveness study of treatment for 24weeks with XR-NTX, an opioid antagonist, versus BUP-NX, a high affinity partial opioid agonist, for opioid dependent patients initiating treatment at 8 short-term residential (detoxification) units and continuing care as outpatients. Up to 600 participants are randomized (1:1) to XR-NTX or BUP-NX. RESULTS: The primary outcome is time to opioid relapse (i.e., loss of persistent abstinence) across the 24-week treatment phase. Differences between arms in the distribution of time-to-relapse will be compared (construction of the asymptotic 95% CI for the hazard ratio of the difference between arms). Secondary outcomes include proportions retained in treatment, rates of opioid abstinence, adverse events, cigarette, alcohol, and other drug use, and HIV risk behaviors; opioid cravings, quality of life, cognitive function, genetic moderators, and cost effectiveness. CONCLUSIONS: XR-NTX and BUP-NX differ considerably in their characteristics and clinical management; no studies to date have compared XR-NTX with buprenorphine maintenance. Study design choices and compromises inherent to a comparative effectiveness trial of distinct treatment regimens are reviewed. CLINICAL TRIAL REGISTRATION: NCT02032433.
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Combinación Buprenorfina y Naloxona/uso terapéutico , Investigación sobre la Eficacia Comparativa/métodos , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Combinación Buprenorfina y Naloxona/economía , Análisis Costo-Beneficio , Preparaciones de Acción Retardada , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Naltrexona/administración & dosificación , Naltrexona/economía , Antagonistas de Narcóticos/economía , National Institute on Drug Abuse (U.S.) , Factores Socioeconómicos , Estados UnidosRESUMEN
AIMS: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. METHODS: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. RESULTS: No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. CONCLUSIONS: Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.
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Analgésicos Opioides/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Trastornos Relacionados con Cocaína/tratamiento farmacológico , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Administración Oral , Adulto , Terapia Cognitivo-Conductual , Preparaciones de Acción Retardada , Método Doble Ciego , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
Nearly 20% of adults receiving treatment for a substance use disorder live with their minor children (Stanger et al., 1999) and women in drug use treatment are twice as likely as men to have children in their household (Wechsberg et al., 1998). Parental drug use impacts the family through reduced family resources such as money and food, and researchers consistently note parenting deficits among substance users (Solis, Shadur, Burns, & Hussong, 2012). Little is known about differences in parenting and mother-child interaction among mothers with different drugs of choice or among mothers of older children, between 8 and 16 years. This study reports the findings from a sample of treatment seeking opioid, alcohol and cocaine using mothers and their 8-16-year-old child. Findings from a mother-child observational task and self-reported parenting measure indicated less undermining autonomy and higher mother maternal acceptance among opioid compared to alcohol addicted mothers. African American mothers were observed to have fewer negative interactional behaviors than Whites and both African American mothers and children self-reported higher firm control and maternal acceptance. Overall, mothers appeared to struggle with effective discipline with older versus younger children. Findings offer useful information to clinicians seeking to effectively tailor their interventions to women and children who present with different drugs of abuse, race/culture and developmental stage of child.
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Alcoholismo/psicología , Trastornos Relacionados con Cocaína/psicología , Relaciones Madre-Hijo/psicología , Trastornos Relacionados con Opioides/psicología , Responsabilidad Parental/psicología , Adolescente , Adulto , Negro o Afroamericano , Alcoholismo/etnología , Análisis de Varianza , Niño , Trastornos Relacionados con Cocaína/etnología , Femenino , Humanos , Masculino , Relaciones Madre-Hijo/etnología , Trastornos Relacionados con Opioides/etnología , Población BlancaRESUMEN
BACKGROUND: Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes. This study tested the efficacy of a newly developed psychosocial intervention, Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T), relative to psychosocial treatment as usual (TAU), for improving treatment outcomes. METHODS: A randomized, 14-week trial with follow-up visits at 6 and 9 months post-randomization conducted at two substance use disorder (SUD) treatment programs. Opioid-dependent adults (i.e., identified patient - IP) enrolled in a residential buprenorphine-detoxification program and their identified concerned significant other (CSO) was randomized to CRAFT-T (n=28 dyads) or TAU (n=24 dyads). CRAFT-T consisted of two sessions with the IP and CSO together and 10 with the CSO alone, over 14 weeks. TAU for the CSOs was primarily educational and referral to self-help. All IPs received treatment as usually provided by the SUD program in which they were enrolled. The primary outcome was time to first IP drop from treatment lasting 30 days or more. Opioid and other drug use were key secondary outcomes. RESULTS: CRAFT-T resulted in a moderate but non-significant effect on treatment retention (p=0.058, hazard ratio=0.57). When the CSO was parental family, CRAFT-T had a large and significant effect on treatment retention (p<0.01, hazard ratio=.040). CRAFT-T had a significant positive effect on IP opioid and other drug use (p<0.0001). CONCLUSION: CRAFT-T is a promising treatment for opioid use disorder but replication is needed to confirm these results.
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Trastornos Relacionados con Opioides/terapia , Cooperación del Paciente/psicología , Psicoterapia/métodos , Adulto , Buprenorfina/uso terapéutico , Terapia Combinada , Femenino , Humanos , Masculino , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Proyectos Piloto , Adulto JovenRESUMEN
OBJECTIVE: To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. METHOD: A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. RESULTS: There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²1 = 15.26, P < .0001), reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²1 = 0.14, P = .70). CONCLUSIONS: The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01641159.
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Ansiolíticos/farmacología , Buspirona/farmacología , Trastornos Relacionados con Cocaína/tratamiento farmacológico , Adulto , Ansiolíticos/administración & dosificación , Ansiolíticos/efectos adversos , Buspirona/administración & dosificación , Buspirona/efectos adversos , Trastornos Relacionados con Cocaína/fisiopatología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Prevención Secundaria , Factores Sexuales , Factores de Tiempo , Resultado del TratamientoRESUMEN
Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.
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Acetilcisteína/uso terapéutico , Abuso de Marihuana/tratamiento farmacológico , Proyectos de Investigación , Acetilcisteína/administración & dosificación , Acetilcisteína/efectos adversos , Adolescente , Adulto , Método Doble Ciego , Femenino , Pruebas Genéticas , Humanos , Masculino , Abuso de Marihuana/epidemiología , Abuso de Marihuana/genética , Persona de Mediana Edad , National Institute on Drug Abuse (U.S.) , Fumar/epidemiología , Estados Unidos , Adulto JovenRESUMEN
OBJECTIVE: To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients. METHOD: A randomized, 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012. Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual (n = 271) or treatment as usual with smoking-cessation treatment (n = 267). All participants received treatment as usual for substance use disorder treatment. Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion (300 mg/d) during weeks 1-10. During post-quit treatment (weeks 4-10), participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence. Weekly proportion of stimulant-abstinent participants during the treatment phase, as assessed by urine drug screens and self-report, was the primary outcome. Secondary measures included other substance/nicotine use outcomes and treatment attendance. RESULTS: There were no significant treatment effects on stimulant-use outcomes, as measured by the primary outcome and stimulant-free days, on drug-abstinence, or on attendance. Participants assigned to treatment as usual with smoking-cessation treatment, relative to those assigned to treatment as usual, had significantly better outcomes for drug-free days at 6-month follow-up (χ(2)(1) = 4.09, P <.05), with a decrease in drug-free days from baseline of -1.3% in treatment as usual with smoking-cessation treatment and of -7.6% in treatment as usual. Participants receiving treatment as usual with smoking-cessation treatment, relative to those receiving treatment as usual, had significantly better outcomes on smoking point-prevalence abstinence (25.5% vs 2.2%; χ(2)(1) = 44.69, P < .001; OR =18.2). CONCLUSIONS: These results suggest that providing smoking-cessation treatment to illicit stimulant-dependent patients in outpatient substance use disorder treatment will not worsen, and may enhance, abstinence from nonnicotine substance use. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01077024.
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Cese del Hábito de Fumar/métodos , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Adulto , Trastornos Relacionados con Anfetaminas/complicaciones , Trastornos Relacionados con Anfetaminas/tratamiento farmacológico , Trastornos Relacionados con Anfetaminas/terapia , Antidepresivos de Segunda Generación/uso terapéutico , Bupropión/uso terapéutico , Trastornos Relacionados con Cocaína/complicaciones , Trastornos Relacionados con Cocaína/tratamiento farmacológico , Trastornos Relacionados con Cocaína/terapia , Consejo , Femenino , Humanos , Masculino , Fumar/tratamiento farmacológico , Fumar/terapia , Trastornos Relacionados con Sustancias/complicaciones , Trastornos Relacionados con Sustancias/terapia , Dispositivos para Dejar de Fumar Tabaco , Resultado del TratamientoRESUMEN
OBJECTIVES: To examine the efficacy of 3 theoretically distinct interventions among substance-abusing runaway adolescents and to explore individual differences in trajectories of change. METHOD: Adolescents (N = 179) between the ages of 12 and 17 were recruited from a runaway shelter in a midwestern city. The sample included 94 females (52.5%) and 85 males (47.5%); the majority of the adolescents were African American (n = 118, 65.9%). Adolescents were randomly assigned to the Community Reinforcement Approach (CRA, n = 57), Motivational Interviewing (MI, n = 61), or Ecologically-Based Family Therapy (EBFT, n = 61). Substance use was assessed at baseline, 3, 6, 9, 12, 18, and 24 months via Form 90 and urine screens. RESULTS: Hierarchical linear modeling revealed statistically significant improvement in frequency of substance use among runaways in all 3 treatment groups, with a slight increase at posttreatment. Latent trajectory profile analysis explored individual differences in change trajectories and yielded a 3-class model. The majority of adolescents (n = 136, 76%) showed reductions in substance use over time, with a slight increase at follow-up (Class 1: Decreasing). Twenty-four (13.4%) adolescents had shown high levels of substance use over time with patterns of increase and decrease (Class 2: Fluctuating high users), and 19 (10.6%) decreased but returned to baseline levels by 2 years postbaseline (Class 3: U shaped). Few differences among treatment conditions were noted; within the "decreasing" group, adolescents in MI treatment showed a quicker decline in their substance use but a faster relapse compared with those receiving EBFT. CONCLUSIONS: These findings suggest that CRA, EBFT, and MI are viable treatments for runaway substance-abusing adolescents.
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Terapia Familiar/métodos , Jóvenes sin Hogar/psicología , Entrevista Motivacional/métodos , Psicoterapia/métodos , Refuerzo en Psicología , Trastornos Relacionados con Sustancias/terapia , Adolescente , Adulto , Niño , Femenino , Humanos , Individualidad , Masculino , Medio Oeste de Estados Unidos/epidemiología , Características de la Residencia , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/orina , Resultado del TratamientoRESUMEN
BACKGROUND: Research suggests that mentholated cigarettes may play a role in cocaine dependence. The purpose of the present study was to expand upon the research on mentholated cigarettes and cocaine dependence and to evaluate the role of mentholated cigarettes in methamphetamine dependence. METHODS: Secondary analysis of a multisite, randomized trial evaluating the impact of smoking-cessation treatment in stimulant-dependent outpatients (N=538). Participants' reasons for concurrent use of cigarettes and illicit stimulants were assessed via self-report. Stimulant-abstinence was measured by self-report and urine drug screens. Smoking cessation was assessed via self-report and carbon monoxide levels. RESULTS: Of the 301 cocaine-dependent participants, 201 (67%) were menthol and 100 (33%) were non-menthol cigarette smokers. Cocaine-dependent participants who smoked menthol, compared to non-menthol, cigarettes were significantly more likely to report that cigarettes prolong their cocaine high (X(2)(1)=16.3, p<.0001, OR=3.58 [95% CI: 1.88-6.79]) and were less likely to be stimulant abstinent during active treatment (W=3.6, p<0.001, d=.39 [95% CI: 0.16-0.62]), at 3-month follow-up (X(2)(1)=14.4, p<0.001, OR=.32 [95% CI: 0.17-0.58]), and at 6-month follow-up (X(2)(1)=4.6, p=0.03, OR=.53 [95% CI: 0.29-0.95]). No parallel differences were found between menthol and non-menthol methamphetamine-dependent smokers. The prevalence of Caucasian menthol smokers was significantly greater in the cocaine-dependent participants (37.2%) than in the methamphetamine-dependent participants (17.61%), (X(2)(1)=14.4, p<.001, OR=2.77 [95% CI:1.62-4.73]). Smoking cessation was not significantly associated with cigarette type for either cocaine- or methamphetamine-dependent participants. CONCLUSIONS: The present results suggest that mentholated cigarettes play a role in cocaine, but not methamphetamine, dependence.
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Trastornos Relacionados con Anfetaminas/complicaciones , Trastornos Relacionados con Anfetaminas/epidemiología , Trastornos Relacionados con Cocaína/complicaciones , Trastornos Relacionados con Cocaína/epidemiología , Mentol/administración & dosificación , Mentol/efectos adversos , Fumar/epidemiología , Productos de Tabaco , Adulto , Trastornos Relacionados con Anfetaminas/psicología , Trastornos Relacionados con Anfetaminas/terapia , Conducta Adictiva/epidemiología , Conducta Adictiva/psicología , Conducta Adictiva/terapia , Trastornos Relacionados con Cocaína/psicología , Trastornos Relacionados con Cocaína/terapia , Femenino , Humanos , Masculino , Prevalencia , Autoadministración , Autoinforme , Fumar/psicología , Cese del Hábito de Fumar/psicología , Cese del Hábito de Fumar/estadística & datos numéricos , Productos de Tabaco/efectos adversos , Resultado del Tratamiento , Población Blanca/psicología , Adulto JovenRESUMEN
AIMS: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. DESIGN: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). SETTING: Intensive outpatient substance treatment programs. PARTICIPANTS: Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. MEASUREMENTS: Urinalysis and self-reports of substance use and 12-step attendance and activities. INTERVENTION: Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. FINDINGS: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. CONCLUSIONS: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU.
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Estimulantes del Sistema Nervioso Central/efectos adversos , Cooperación del Paciente , Grupos de Autoayuda , Trastornos Relacionados con Sustancias/rehabilitación , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , National Institute on Drug Abuse (U.S.) , Recurrencia , Derivación y Consulta/organización & administración , Índice de Severidad de la Enfermedad , Detección de Abuso de Sustancias , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
AIMS: Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. METHODS: A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. RESULTS: Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. CONCLUSIONS: We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.
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Investigación Biomédica/métodos , Ensayos Clínicos como Asunto/métodos , Drogas Ilícitas , Trastornos Relacionados con Sustancias/rehabilitación , Alcoholismo/rehabilitación , Consenso , Determinación de Punto Final , Humanos , Autoinforme , Detección de Abuso de Sustancias/métodos , Síndrome de Abstinencia a Sustancias/diagnóstico , Tabaquismo/rehabilitación , Resultado del TratamientoRESUMEN
OBJECTIVE: The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. METHOD: Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. RESULTS: Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. CONCLUSIONS: PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.
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Terapia Cognitivo-Conductual/métodos , National Institute on Drug Abuse (U.S.) , Educación del Paciente como Asunto/métodos , Trastornos por Estrés Postraumático/terapia , Trastornos Relacionados con Sustancias/terapia , Adulto , Alcoholismo/diagnóstico , Alcoholismo/epidemiología , Alcoholismo/terapia , Comorbilidad , Diagnóstico Dual (Psiquiatría)/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Acontecimientos que Cambian la Vida , Estudios Longitudinales , Cadenas de Markov , Psicoterapia de Grupo/métodos , Índice de Severidad de la Enfermedad , Trastornos por Estrés Postraumático/diagnóstico , Trastornos por Estrés Postraumático/epidemiología , Trastornos Relacionados con Sustancias/diagnóstico , Trastornos Relacionados con Sustancias/epidemiología , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. METHOD: A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. RESULTS: Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P < .0001) and in cigarettes per day during the post-quit phase (P = .016). Relative to placebo, OROS-MPH increased blood pressure and heart rate to a statistically, but not clinically, significant degree (P < .05); medication discontinuation did not differ significantly between treatments. CONCLUSIONS: Treatment for ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. TRIAL REGISTRATION: clinical trials.gov Identifier: NCT00253747.