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OBJECTIVES: This paper outlines the experience developing Addiction Medicine Practice-Based Research Network (AMNet), which promotes the adoption of patient-reported outcome measures (PROMs) and measurement-based care in outpatient addiction treatment practices and creates a platform for quality improvement and research. METHODS: From August 2019 to July 2023, the AMNet team selected patient-reported outcome measures for implementation in the American Psychiatric Association's clinical data registry (PsychPRO), recruited addiction medicine providers, and collected PROMs data. RESULTS: AMNet selected 12 PROMs for implementation in PsychPRO. Through July 2023, 1565 providers expressed interest, of whom 216 of the 929 eligible providers (23%) attended an onboarding call/webinar. Two hundred six providers (95%) from 54 practices returned Participation Agreements. Subsequently, 65 providers (32%) from 39 practices withdrew, resulting in 141 (68%) providers from 15 practices. From November 2020 to July 2023, 38 providers submitted PROMs data using 1 of 3 PsychPRO patient portals. Sixteen of the 53 providers (30%) who signed up for the initial portal collected data from 468 patients. As of July 2023, 83 of the 141 providers (59%) opted to submit PROMs data from their own portal or electronic health record. CONCLUSIONS: Next steps will include continued recruitment of providers, addressing barriers to data transfer and integrating data from providers' portals into the registry to create a platform for future research.
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Objective: To test esmethadone (REL-1017) as adjunctive treatment in patients with major depressive disorder (MDD) and inadequate response to standard antidepressants.Methods: In this phase 3, double-blind, placebo-controlled trial, outpatients with MDD (DSM-5) were randomized to daily oral esmethadone (75 mg on day 1, followed by 25 mg daily on days 2 through 28) or placebo between December 2020 and December 2022. The primary efficacy measure was change from baseline (CFB) to day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score. The intent-to-treat (ITT) population included all randomized participants. The per-protocol (PP) population included completers without major protocol deviations impacting assessment. Post hoc analyses included participants with severe depression (baseline MADRS score ≥35).Results: For the ITT analysis (n = 227), mean CFB was 15.1 (SD 11.3) for esmethadone (n = 113) and 12.9 (SD 10.4) for placebo (n = 114), with a mean difference (MD) of 2.3, which was not statistically significant (P = .154; Cohen effect size [ES] = 0.21). Remission rates were 22.1% and 13.2% (P = .076), and response rates were 39.8% and 27.2% (P = .044) with esmethadone and placebo, respectively. For the PP analysis (n = 198), mean CFB was 15.6 (SD 11.2) for esmethadone (n = 101) and 12.5 (SD 9.9) for placebo (n = 97), with an MD of 3.1 (P = .051; ES =0.29). In post hoc analyses of patients with baseline MADRS ≥35 in the ITT population (n = 112), MD was 6.9; P = .0059; ES = 0.57, and for the PP population (n = 98), MD was 7.9; P = .0015; ES = 0.69. Adverse events (AEs) were predominantly mild or moderate and transient, with no significant differences between groups.Conclusions: The primary end point was not met. Esmethadone showed stronger efficacy in PP than in ITT analyses, with the discrepancy not attributable to AEs impacting treatment adherence. Significant efficacy occurred in post hoc analyses of patients with severe depression. Esmethadone was well tolerated, consistent with prior studies.Trial Registration: ClinicalTrials.gov identifier: NCT04688164.
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Antidepresivos , Trastorno Depresivo Mayor , Humanos , Trastorno Depresivo Mayor/tratamiento farmacológico , Masculino , Adulto , Femenino , Método Doble Ciego , Persona de Mediana Edad , Antidepresivos/efectos adversos , Antidepresivos/administración & dosificación , Antidepresivos/uso terapéutico , Trastorno Depresivo Resistente al Tratamiento/tratamiento farmacológico , Resultado del Tratamiento , Quimioterapia CombinadaRESUMEN
OBJECTIVE: The authors investigated adaptations to outpatient care delivery and changes in treatment demand and engagement among patients receiving medications for opioid use disorder (MOUD) in the months after the declaration of the COVID-19 public health emergency in 2020. METHODS: Data were collected through an online survey (June-November 2020) of outpatient MOUD prescribers. The survey obtained information on outpatient practices' adaptations to MOUD treatment and urine drug screening (UDS) and elicited provider views on the effects of the COVID-19 pandemic on patient demand for, and engagement in, treatment. Multivariable regression analyses were used to examine associations among practice characteristics, patient engagement, and service adaptations. RESULTS: Of 516 respondents, 74% reported adaptations to MOUD delivery during the pandemic. Most respondents implemented virtual visits for initial (67%) and follow-up (77%) contacts. Prescribers of buprenorphine were more likely than those who did not prescribe the medication to report MOUD adaptations. Among respondents reporting any MOUD adaptation, 77% made adaptations to their UDS practices. Among 513 respondents who answered COVID-19-related questions, 89% reported that the pandemic had affected the treatment and engagement of their patients. Of these respondents, 30% reported increased difficulty with patient engagement, and 45% reported that their patients preferred virtual visits during this period, whereas 18% endorsed patient preference for in-person visits. CONCLUSIONS: Telehealth and federal regulatory easements in response to the COVID-19 pandemic enabled providers to continue treating patients for opioid use disorder in 2020. The results suggest that care adaptations and changes in patient demand and engagement were common in the practices surveyed.
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COVID-19 , Trastornos Relacionados con Opioides , Humanos , Pandemias , Participación del Paciente , Atención Ambulatoria , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/epidemiologíaRESUMEN
New medicines containing classic hallucinogenic and entactogenic psychedelic substance are under development for various psychiatric and neurological disorders. Many of these, including psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are Schedule I controlled substances of the United States Controlled Substances Act (US CSA), and similarly controlled globally. The implications of the CSA for research and medicines development, the path to approval of medicines, and their subsequent removal from Schedule I in the US are discussed. This entire process occurs within the framework of the CSA in the US and its counterparts internationally in accordance with international drug control treaties. Abuse potential related research in the US informs the eight factors of the CSA which provide the basis for rescheduling actions that must occur upon approval of a drug that contains a Schedule I substance. Abuse-related research also informs drug product labeling and the risk evaluation and mitigation strategies (REMS) will likely be required for approved medicines. Human abuse potential studies typically employed in CNS drug development may be problematic for substances with strong hallucinogenic effects such as psilocybin, and alternative strategies are discussed. Implications for research, medicinal development, and controlled substance scheduling are presented in the context of the US CSA and FDA requirements with implications for global regulation. We also discuss how abuse-related research can contribute to understanding mechanisms of action and therapeutic effects as well as the totality of the effects of the drugs on the brain, behavior, mood, and the constructs of spirituality and consciousness.
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Alucinógenos , Trastornos Relacionados con Sustancias , Sustancias Controladas , Alucinógenos/farmacología , Alucinógenos/uso terapéutico , Humanos , Dietilamida del Ácido Lisérgico/farmacología , Dietilamida del Ácido Lisérgico/uso terapéutico , Psilocibina/uso terapéutico , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Estados UnidosRESUMEN
This column describes the collaboration among the American Psychiatric Association (APA), American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse to create the Addiction Medicine Practice-Based Research Network (AMNet). The collaboration, which aims to address the opioid overdose epidemic in the United States, leverages the APA's clinical data registry (PsychPRO) and is recruiting office-based addiction medicine and addiction psychiatry practices for AMNet. AMNet aims to address knowledge gaps regarding patient care in such practices, facilitate performance improvement efforts, and serve as a research platform.
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Medicina de las Adicciones , Trastornos Relacionados con Opioides , Humanos , Trastornos Relacionados con Opioides/epidemiología , Estados UnidosRESUMEN
This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
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Buprenorfina , Trastornos Relacionados con Opioides , Adulto , Buprenorfina/uso terapéutico , Protocolos Clínicos , Preparaciones de Acción Retardada/uso terapéutico , Humanos , Inyecciones Intramusculares , Cárceles Locales , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole. METHODS: This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative "value" of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials. DISCUSSION: Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.
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Análisis Costo-Beneficio/economía , Preparaciones de Acción Retardada , Naltrexona , Antagonistas de Narcóticos , Trastornos Relacionados con Opioides , Aceptación de la Atención de Salud , Prisioneros , Preparaciones de Acción Retardada/economía , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Naltrexona/economía , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/economía , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/economía , Prisiones , Calidad de Vida , Resultado del TratamientoRESUMEN
BACKGROUND: It has been estimated that approximately 15% of people who are incarcerated in the US have histories of opioid use disorder. Relapse to opioid use after release from prison poses a serious risk of HIV infection. Prison-initiated buprenorphine may help to reduce HIV infection given the association between opioid use and HIV-risk behaviors. METHODS: The present study is a secondary analysis of longitudinal data gathered from a randomized controlled trial of buprenorphine-naloxone for people who were incarcerated (N = 211) between 2008 and 2012. It compares the impact of assignment to initiate buprenorphine in prison (N = 106 randomized, N = 104 analyzed) versus in the community (N = 107 randomized, N = 107 analyzed) and whether or not participants entered community treatment on the frequency of HIV-risk behaviors in the 12 months following release from prison. Data were analyzed hierarchically and for each outcome variable, a multilevel, over-dispersed Poisson model was fit to the data. Outcome variables were the number of times the following behaviors occurred in the last 30 days: (1) having sex without a condom (2) injecting drugs (3) using unsterilized needles, and (4) sharing injection paraphernalia. RESULTS: Participants assigned to begin buprenorphine in the community experienced a greater decrease in injection drug use over time compared to participants assigned to begin buprenorphine in prison. There were no significant associations between treatment assignment or community treatment entry and instances of having sex without a condom, sharing injection paraphernalia, or using unsterilized needles. CONCLUSIONS: Overall, the present study did not find support for the initiation of buprenorphine in prison (as opposed to the community) as a means to reduce incidences of HIV-risk behaviors. Avenues for future research in the nexus of HIV-risk reduction, criminal justice, and pharmacotherapy are discussed. Trial registration This study was supported by the National Institute on Drug Abuse (NIDA), Buprenorphine for Prisoners (PI: Kinlock; R01DA021579). ClinicalTrials.gov identifier: NCT00574067.
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Combinación Buprenorfina y Naloxona/uso terapéutico , Infecciones por VIH/epidemiología , Trastornos Relacionados con Opioides/tratamiento farmacológico , Prisiones , Asunción de Riesgos , Adolescente , Adulto , Combinación Buprenorfina y Naloxona/administración & dosificación , Femenino , Humanos , Masculino , Compartición de Agujas , Factores Socioeconómicos , Abuso de Sustancias por Vía Intravenosa/epidemiología , Estados Unidos/epidemiología , Sexo Inseguro , Adulto JovenRESUMEN
BACKGROUND: Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings. METHODS: Male and female individuals under probation or parole supervision (Nâ¯=â¯320) with histories of opioid use disorder will be enrolled in this randomized controlled trial. Participants will be randomized to one of two study arms: Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine using the MedicaSafe dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to a community program; or Treatment as Usual (TAU): Participants will receive a referral to buprenorphine pharmacotherapy treatment in the community. Treatment outcomes will be: (a) illicit opioid oral saliva drug test results; and (b) treatment adherence (i. entered community based treatment; ii. number of days receiving opioid treatment). RESULTS: We describe the background and rationale for the study, its aims, hypotheses, and study design. CONCLUSIONS: If shown to increase compliance rates with conditions of probation and parole, buprenorphine treatment co-located at community supervision field offices could have a major impact on delivery of buprenorphine treatment to the criminal justice population. The public health impact of the proposed study would be widespread because this intervention could be implemented throughout areas of the US.
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Buprenorfina/uso terapéutico , Criminales , Antagonistas de Narcóticos/uso terapéutico , Tratamiento de Sustitución de Opiáceos/métodos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Adolescente , Adulto , Anciano , Buprenorfina/administración & dosificación , Continuidad de la Atención al Paciente , Femenino , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Antagonistas de Narcóticos/administración & dosificación , Proyectos de Investigación , Adulto JovenRESUMEN
BACKGROUND: This secondary analysis of a randomized trial examines the association between initiation of buprenorphine treatment prior to, versus post-release, and rearrests during the 12-months following release. METHODS: Official rearrest data (Nâ¯=â¯199) for the 12-months post-release were examined. Four outcomes were measured: (1) rearrested (yes/no), (2) time to rearrest, (3) number of rearrests, and (4) severity of charges (less severe vs. severe). RESULTS: A minority (43.1%) of the sample were rearrested (Nâ¯=â¯91). There were no significant differences between study conditions in the proportion of rearrested participants [Pâ¯=â¯0.28] nor in the mean number of arrests [P â¯=â¯0.15]. Likewise, the condition was not a significant predictor of the hazard of rearrest [pâ¯=â¯0.10]. The mean number of days until rearrest for the in prison vs. post-release buprenorphine conditions were not significantly different (205.8 days (SD â¯=â¯104.6) vs. 170.8 days (SD â¯=â¯113.1), respectively; P â¯=â¯0.13]. Treatment condition was not a significant predictor of the likelihood of rearrest for a severe crime compared to a less severe crime [P â¯=â¯0.09]. CONCLUSION: Despite the parent study finding of higher rates of post-release drug treatment entry in the group assigned to start buprenorphine treatment prior to, compared to post-release, there were no significant differences in the proportion of individuals arrested, the mean number of arrests, the time to first arrest, or the severity of their charges.
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Buprenorfina/uso terapéutico , Aplicación de la Ley/métodos , Tratamiento de Sustitución de Opiáceos/métodos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Prisioneros/psicología , Adulto , Crimen/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de TiempoRESUMEN
BACKGROUND AND AIMS: Extended-release naltrexone (XR-NTX), a µ-opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine-naloxone. We report outcomes for XR-NTX in Vivitrol's Cost and Treatment Outcomes Registry. DESIGN: Observational, open-label, single-arm, multi-center registry assessing baseline characteristics and clinical and health-related quality-of-life outcomes associated with XR-NTX treatment in clinical practice. SETTING: 32 US treatment centers from 2011 to 2013. PARTICIPANTS: Patients with opioid dependence who were prescribed XR-NTX treatment and then enrolled into the registry. MEASUREMENTS: Monthly visits were evaluated for the full population and for patient ubgroups retrospectively, defined by injection number, focusing on the period between baseline and month 6 (1-, 2/3- or 6-XR-NTX). FINDINGS: Of 403 enrolled patients, 395 were analyzed. Most patients (n = 349) received out-patient care. On average, patients received five injections (median = 3; range = 1-25). The median number of injections administered within 6 months was higher in patients who at baseline were employed (three versus two unemployed, P = 0.02) or had private insurance (five versus two self-payment, P = 0.005; versus two state-funded, P < 0.001). The 1-, 2/3- and 6-XR-NTX groups had 132, 152 and 111 patients, respectively. At baseline, the 6-XR-NTX patients were more likely to meet normal/minimal mental illness criteria and attend school and less likely to report recent drug use. Within 6 months, the 6-XR-NTX group demonstrated improvements in employment, mental health and psychosocial functioning, and decreases in opioid craving, drug use and drug-related behavior. CONCLUSIONS: Among opioid-dependent people receiving XR-NTX treatment, better mental health, higher education and lower recent drug use at baseline are associated with greater treatment duration; in turn, longer treatment duration is associated with lower relapse rates and improved outcomes generally.
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Ansia , Empleo , Salud Mental , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Adolescente , Adulto , Escolaridad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Avatar-assisted therapy (AAT) is a novel and emerging technology that uses the Internet to enable clinicians and clients in substance abuse treatment to participate in group counseling sessions from separate and remote locations in real time through the use of avatars and virtual environments. OBJECTIVES: The current study is a pilot proof-of-concept feasibility study involving individuals in outpatient substance abuse treatment. This report addresses two questions: (1) are individuals who present for substance abuse treatment interested in receiving AAT and (2) what factors are associated with better treatment success. METHODS: Individuals who presented at the treatment clinic who met study eligibility criteria, and provided their written informed consent to participate, were included in the current study (N = 59; 78% male). RESULTS: Twenty-eight (47.5%) participants completed 16 weeks of treatment and attended more sessions compared to non-completers (M = 14.3 vs. 7.5 p < .05). Those individuals who completed treatment were less likely to have a positive urine drug screen at baseline (21.5 vs. 78.6%; p < .05). Furthermore, those individuals who successfully completed treatment were less likely to have positive urine drug screens during treatment compared to those who did not complete (29.7% vs. 70.3%, p < .05). There were no arrests during treatment for completers and non-completers. CONCLUSION: Poor retention in substance use disorder treatment has long been a major problem for public health. AAT is a feasible approach that has the potential to expand treatment to individuals who might have difficulty accessing treatment. Moreover, AAT may be appealing to clients who are concerned about anonymity and confidentiality.
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Consejo/métodos , Consulta Remota/métodos , Trastornos Relacionados con Sustancias/terapia , Terapia Asistida por Computador/métodos , Adolescente , Adulto , Femenino , Humanos , Internet , Masculino , Proyectos Piloto , Trastornos Relacionados con Sustancias/psicología , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. METHODS: Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. RESULTS: Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18). CONCLUSIONS: Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior.
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Buprenorfina/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/prevención & control , Trastornos Relacionados con Opioides/rehabilitación , Prisioneros , Adulto , Buprenorfina/efectos adversos , Trastornos Relacionados con Cocaína/epidemiología , Trastornos Relacionados con Cocaína/orina , Consejo , Crimen/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Dependencia de Heroína/rehabilitación , Humanos , Masculino , Persona de Mediana Edad , Antagonistas de Narcóticos/efectos adversos , Recurrencia , Caracteres Sexuales , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases has been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment. METHODS: Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial. Participants are randomized to one of two study arms: 1) [XR-NTX-OTx] One injection of long-acting naltrexone in prison, followed by 6 monthly injections post-release at a community opioid treatment program; or 2) [XR-NTX+ MMTx] One injection of long-acting naltrexone in prison followed by 6 monthly injections post-release at the patient's place of residence utilizing mobile medical treatment. The primary outcomes are: treatment adherence; opioid use; criminal activity; re-arrest; reincarceration; and HIV risk-behaviors. RESULTS: We describe the background and rationale for the study, its aims, hypotheses, and study design. CONCLUSIONS: The use of long-acting injectable naltrexone may be a promising form of treatment for pre-release prisoners. Finally, as many individuals in the criminal justice system drop out of treatment, this study will assess whether treatment at their place of residence will improve adherence and positively affect treatment outcomes. ClinicalTrials.gov: NCT02867124.
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Atención a la Salud/métodos , Unidades Móviles de Salud , Naltrexona/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Trastornos Relacionados con Opioides/tratamiento farmacológico , Prisioneros , Prisiones , Centros de Tratamiento de Abuso de Sustancias , Crimen/estadística & datos numéricos , Preparaciones de Acción Retardada , Femenino , Infecciones por VIH , Humanos , Inyecciones Intramusculares , Masculino , Cumplimiento de la Medicación , Recurrencia , Asunción de Riesgos , Estados UnidosRESUMEN
IMPORTANCE: The effectiveness of buprenorphine treatment of opioid dependence is limited by suboptimal medication adherence, abuse, and diversion. OBJECTIVE: To determine whether 6-month buprenorphine implants are noninferior to daily sublingual buprenorphine as maintenance treatment for opioid-dependent patients with stable abstinence. DESIGN, SETTING, AND PARTICIPANTS: Outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study conducted at 21 US sites from June 26, 2014, through May 18, 2015. Outpatients were prescribed daily sublingual buprenorphine for 6 months or more, were abstinent while taking 8 mg/d or less of sublingual buprenorphine for 90 days or longer, and were determined to be clinically stable by their physician. INTERVENTIONS: Participants were randomized to receive sublingual buprenorphine plus 4 placebo implants or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants (expected efficacy, 24 weeks). MAIN OUTCOME MEASURE: The primary end point was between-group difference in proportion of responders (≥4 of 6 months without opioid-positive urine test result [monthly and 4 times randomly] and self-report). The noninferiority established for the lower bound of the 95% confidence interval was greater than -0.20 (P < .025). Secondary end points included cumulative percentage of negative opioid urine results, abstinence, and time to first illicit opioid use. Safety was assessed by adverse event reporting. RESULTS: Of 177 participants (mean age, 39 years; 40.9% female), 90 were randomized to sublingual buprenorphine with placebo implants and 87 to buprenorphine implants with sublingual placebo; 165 of 177 (93.2%) completed the trial. Eighty-one of 84 (96.4%) receiving buprenorphine implants and 78 of 89 (87.6%) receiving sublingual buprenorphine were responders, an 8.8% difference (1-sided 97.5% CI, 0.009 to ∞; P < .001 for noninferiority). Over 6 months, 72 of 84 (85.7%) receiving buprenorphine implants and 64 of 89 (71.9%) receiving sublingual buprenorphine maintained opioid abstinence (hazard ratio, 13.8; 95% CI, 0.018-0.258; P = .03). Non-implant-related and implant-related adverse events occurred in 48.3% and 23% of the buprenorphine implant group and in 52.8% and 13.5% of participants in the sublingual buprenorphine group, respectively. CONCLUSIONS AND RELEVANCE: Among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine, the use of buprenorphine implants compared with continued sublingual buprenorphine did not result in an inferior likelihood of remaining a responder. However, the study population had an exceptionally high response rate in the control group, and further studies are needed in broader populations to assess the efficacy in other settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02180659.
Asunto(s)
Buprenorfina/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Trastornos Relacionados con Opioides/tratamiento farmacológico , Administración Sublingual , Adulto , Analgésicos Opioides/sangre , Método Doble Ciego , Esquema de Medicación , Implantes de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , AutoinformeRESUMEN
BACKGROUND: In a previously reported randomized controlled trial, formerly opioid-dependent prisoners were more likely to enter community drug abuse treatment when they were inducted in prison onto buprenorphine/naloxone (hereafter called buprenorphine) than when they received counseling without buprenorphine in prison (47.5% vs. 33.7%, p=0.012) (Gordon et al., 2014). In this communication we report on the results of the induction schedule and the adverse event profile seen in pre-release prisoners inducted onto buprenorphine. METHOD: This paper examines the dose induction procedure, a comparison of the proposed versus actual doses given per week, and side effects reported for 104 adult participants who were randomized to buprenorphine treatment in prison. Self-reported side effects were analyzed using generalized estimated equations to determine changes over time in side effects. RESULTS: Study participants were inducted onto buprenorphine at a rate faster than the induction schedule. Of the 104 (72 males, 32 females) buprenorphine recipients, 64 (37 males, 27 females) remained on medication at release from prison. Nine participants (8.6%) discontinued buprenorphine because of unpleasant opioid side effects. There were no serious adverse events reported during the in-prison phase of the study. Constipation was the most frequent symptom reported (69 percent). CONCLUSION: Our findings suggest that buprenorphine administered to non-opioid-tolerant adults should be started at a lower, individualized dose than customarily used for adults actively using opioids, and that non-opioid-tolerant pre-release prisoners can be successfully inducted onto therapeutic doses prior to release.
Asunto(s)
Analgésicos Opioides/administración & dosificación , Combinación Buprenorfina y Naloxona/administración & dosificación , Tratamiento de Sustitución de Opiáceos/métodos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Prisioneros , Adulto , Consejo , Femenino , Humanos , Masculino , Persona de Mediana Edad , PrisionesRESUMEN
This was a Phase 4, pilot, open-label feasibility study of extended-release injectable naltrexone (XR-NTX) administered to pre-release prisoners having a history of pre-incarceration opioid disorder. We evaluated the relationship between XR-NTX adherence and criminal recidivism (re-arrest and re-incarceration) and opioid and cocaine use. Twenty-seven pre-release male and female prisoners who had opioid disorders during the year prior to index incarceration were recruited and received one XR-NTX injection once each month for 7 months (1 injection pre-release from prison and 6 injections in the community) and of those 27, 10 (37%) were retained in treatment at 7-months post release. Results indicate those completing 6 compared to those completing <6 injections were less likely to test positive for opioids in the community (0% vs. 62.5%, respectively; p=0.003). Although not statistically significant, individuals who did not complete all 6 injections were more likely to be re-arrested compared to those completing all 6 community injections (31.3% vs. 0%, respectively; p=0.123). Contingent upon further study of a randomized controlled trial, XR-NTX may be a feasible option in the prison setting in view of the lack of potential for diversion. Furthermore, these data suggest that completing the entire course of treatment (6 injections) may reduce opioid use and, to a lesser degree, re-arrest and re-incarceration.
Asunto(s)
Naltrexona/farmacología , Antagonistas de Narcóticos/farmacología , Trastornos Relacionados con Opioides/prevención & control , Prisioneros , Adulto , Preparaciones de Acción Retardada , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Naltrexona/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Proyectos Piloto , Resultado del TratamientoRESUMEN
BACKGROUND AND OBJECTIVES: Most studies on e-cigarettes have come from population-based surveys. The current research aimed to provide initial data on e-cigarette awareness, perceptions, use, and reasons for use among adults seeking substance use treatment. METHODS: A survey was conducted among 198 participants ≥18 years old in a community-based outpatient substance use treatment program. RESULTS: Of the 198 participants, 69% currently smoked cigarettes, 92% were aware of e-cigarettes, and 58% had ever used e-cigarettes. The proportion of the number of participants who had ever used e-cigarettes to the number who currently smoked (89.7%) appeared higher than the corresponding proportion in the 2012-13 National Adult Tobacco Survey (78.3%). Almost half of the sample who reported ever using e-cigarettes endorsed quitting or reducing smoking as a reason for use, and 32% endorsed reasons for use relating to curiosity/experimentation. A greater likelihood of e-cigarette ever-use was significantly associated with younger age (adjusted odds ratio [AOR] = 0.94, 95%confidence interval [CI] = 0.90, 0.98) and perceptions related to using e-cigarettes in public places where smoking cigarettes is not allowed (AOR = 2.96, 95%CI = 1.18, 7.42) but was not associated with primary drug of choice. DISCUSSION AND CONCLUSIONS: E-cigarette use in adults seeking substance use treatment appears higher than it is in the US general population of smokers. The high frequency of use may be due to curiosity/experimentation or attempts to quit or reduce smoking. SCIENTIFIC SIGNIFICANCE: Future research may consider how e-cigarettes interact with other substance use and affect high rates of nicotine and tobacco use in this population.