An Item Bank for Abuse of Prescription Pain Medication from the Patient-Reported Outcomes Measurement Information System (PROMIS®).

OBJECTIVE: There is a need to monitor patients receiving prescription opioids to detect possible signs of abuse. To address this need, we developed and calibrated an item bank for severity of abuse of prescription pain medication as part of the Patient-Reported Outcomes Measurement Information System (PROMIS ® ). METHODS: Comprehensive literature searches yielded an initial bank of 5,310 items relevant to substance use and abuse, including abuse of prescription pain medication, from over 80 unique instruments. After qualitative item analysis (i.e., focus groups, cognitive interviewing, expert review, and item revision), 25 items for abuse of prescribed pain medication were included in field testing. Items were written in a first-person, past-tense format, with a three-month time frame and five response options reflecting frequency or severity. The calibration sample included 448 respondents, 367 from the general population (ascertained through an internet panel) and 81 from community treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network. RESULTS: A final bank of 22 items was calibrated using the two-parameter graded response model from item response theory. A seven-item static short form was also developed. The test information curve showed that the PROMIS ® item bank for abuse of prescription pain medication provided substantial information in a broad range of severity. CONCLUSION: The initial psychometric characteristics of the item bank support its use as a computerized adaptive test or short form, with either version providing a brief, precise, and efficient measure relevant to both clinical and community samples.

Evaluating PROMIS® instruments and methods for patient-centered outcomes research: Patient and provider voices in a substance use treatment setting.

PURPOSE: Our work as a primary research site of the Patient-Reported Outcomes Measurement Information System (PROMIS®), combined with support from the Patient-Centered Outcomes Research Institute, allowed us to evaluate the real-world applicability and acceptability of PROMIS measures in an addiction medicine setting. METHODS: As part of a 3-month prospective observational study, 225 outpatients at a substance abuse treatment clinic completed PROMIS item banks for alcohol use (as well as 15 additional item banks from 8 other PROMIS domains, including emotional distress, sleep, and pain), with assessments at intake, 1-month follow-up, and 3-month follow-up. A subsample of therapists and their patients completed health domain importance ratings and qualitative interviews to elicit feedback regarding the content and format of the patients' assessment results. RESULTS: The importance ratings revealed that depression, anxiety, and lack of emotional support were rated highest of the non-alcohol-related domains among both patients and clinicians. General alcohol use was considered most important by both patients and clinicians. Based on their suggestions, changes were made to item response feedback to facilitate comprehension and communication. CONCLUSIONS: Both therapists and patients agreed that their review of the graphical display of scores, as well as individual item responses, helped them to identify areas of greatest concern and was useful for treatment planning. The results of our pilot work demonstrated the value and practicality of incorporating a comprehensive health assessment within a substance abuse treatment setting.

Differential Impact of Depressive and Manic Mood States on Alcohol Craving in Comorbid Bipolar Alcoholism: Preliminary Findings.

OBJECTIVES: To examine the differential impact of depressive and manic mood states on alcohol craving in patients with bipolar disorder and comorbid alcoholism. METHODS: Forty-four men and women, ages 18-65, with DSM-IV-TR comorbid diagnoses of bipolar I disorder and alcohol dependence were assessed over a three-month period to examine the extent to which their depressive and manic symptoms were associated with alcohol cravings (i.e., desire to use and not to use alcohol) at each assessment point, controlling for age, ethnicity, socio-economic status, baseline alcohol use, and number of assessments. RESULTS: Both manic and depressive symptoms were associated with greater desire to use alcohol. Only depressive symptomatology was associated with reduced desire not to use alcohol, and desire not to use alcohol declined over the course of the three-month treatment period. CONCLUSION: Whereas enhanced desire to drink alcohol may be a conditioned reaction to both manic and depressed mood states, desire not to drink alcohol may be more of an indicator of treatment motivation, which is negatively affected by depressed mood. Depressive symptoms may warrant prioritization and aggressive targeting early in treatment given that desire to refrain from alcohol use was only influenced by depressive symptoms and declined over the course of treatment.

Contingency management for patients with dual disorders in intensive outpatient treatment for addiction.

OBJECTIVE: This quality improvement program evaluation investigated the effectiveness of contingency management for improving retention in treatment and positive outcomes among patients with dual disorders in intensive outpatient treatment for addiction. METHODS: The effect of contingency management was explored among a group of 160 patients exposed to contingency management (n = 88) and not exposed to contingency management (no contingency management, n = 72) in a six-week partial hospitalization program. Patients referred to the partial hospitalization program for treatment of substance use and comorbid psychiatric disorders received diagnoses from psychiatrists and specialist clinicians according to the Diagnostic and Statistical Manual of the American Psychiatric Association. A unique application of the contingency management "fishbowl" method was used to improve the consistency of attendance at treatment sessions, which patients attended 5 days a week. Days attending treatment and drug-free days were the main outcome variables. Other outcomes of interest were depression, anxiety and psychological stress, coping ability, and intensity of drug cravings. RESULTS: Patients in the contingency management group attended more treatment days compared to patients in the no contingency management group; M = 16.2 days (SD = 10.0) versus M = 9.9 days (SD = 8.5), respectively; t = 4.2, df = 158, p <.001. No difference was found between the treatment groups on number of drug-free days. Psychological stress and drug craving were inversely associated with drug-free days in bivariate testing (r = -.18, p <.02; r = -.31, p <.001, respectively). Treatment days attended and drug craving were associated with drug-free days in multivariate testing (B =.05, SE =.01, ß =.39, t = 4.9, p <.001; B = -.47; SE =.12, ß = -.30, t = -3.9, p <.001, respectively; Adj. R(2) =.21). Days attending treatment partially mediated the relationship between exposure to contingency management and self-reported drug-free days. CONCLUSIONS: Contingency management is a valuable adjunct for increasing retention in treatment among patients with dual disorders in partial hospitalization treatment. Exposure to contingency management increases retention in treatment, which in turn contributes to increased drug-free days. Interventions for coping with psychological stress and drug cravings should be emphasized in intensive dual diagnosis group therapy.

How practice and science are balanced and blended in the NIDA Clinical Trials Network: the bidirectional process in the development of the STAGE-12 protocol as an example.

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.

Neuropsychiatric aspects of coinfection with HIV and hepatitis C virus.

The increasing health care crisis of coinfection with hepatitis C virus (HCV) and HIV has recently attracted the attention of research in the areas of psychiatric and neurocognitive complications related to coinfection. The preliminary data suggest that HIV/HCV coinfection has neurocognitive and psychiatric effects. This review summarizes the findings of what is known about the neurocognitive and psychiatric aspects of HIV/HCV coinfection and discusses the clinical implications and challenges in working with coinfected persons. An integrated, flexible, and interdisciplinary team approach model of treating patients who are coinfected is presented with specific recommendations for clinicians working with this population.

A randomized trial of integrated group therapy versus group drug counseling for patients with bipolar disorder and substance dependence.

OBJECTIVE: Although bipolar disorder and substance use disorder frequently co-occur, there is little information on the effectiveness of behavioral treatment for this population. Integrated group therapy, which addresses the two disorders simultaneously, was compared with group drug counseling, which focuses on substance use. The authors hypothesized that patients receiving integrated group therapy would have fewer days of substance use and fewer weeks ill with bipolar disorder. METHOD: A randomized controlled trial compared 20 weeks of integrated group therapy or group drug counseling with 3 months of posttreatment follow-up. Sixty-two patients with bipolar disorder and current substance dependence, treated with mood stabilizers for >or=2 weeks, were randomly assigned to integrated group therapy (N=31) or group drug counseling (N=31). The primary outcome measure was the number of days of substance use. The primary mood outcome was the number of weeks ill with a mood episode. RESULTS: Intention-to-treat analysis revealed significantly fewer days of substance use for integrated group therapy patients during treatment and follow-up. Groups were similar in the number of weeks ill with bipolar disorder during treatment and follow-up, although integrated group therapy patients had more depressive and manic symptoms. CONCLUSIONS: Integrated group therapy, a new treatment developed specifically for patients with bipolar disorder and substance dependence, appears to be a promising approach to reduce substance use in this population.

Predictors and Outcomes of Twelve-Step Sponsorship of Stimulant Users: Secondary Analyses of a Multisite Randomized Clinical Trial.

OBJECTIVE: This secondary data analysis explored predictors and outcomes of having a 12-step sponsor among individuals receiving treatment for stimulant use disorders, inclusive of four types of 12-step groups (Narcotics Anonymous, Alcoholics Anonymous, Cocaine Anonymous, and Crystal Meth Anonymous). METHOD: For a multisite randomized clinical trial, participants (N = 471; 59% women) were recruited among adult patients in 10 U.S. community treatment programs. Participants were randomized into treatment as usual (TAU) or a 12-step facilitation (TSF) intervention: Stimulant Abuser Groups to Engage in 12-Step (STAGE-12). Logistic regression analyses explored the extent to which participants obtained sponsors, including the extent to which treatment condition and other predictors (12-step experiences, expectations, and beliefs) were associated with having a sponsor. The relationship between end-of-treatment sponsorship and follow-up substance use outcomes was also tested. RESULTS: Participants were more likely to have a sponsor at the end of treatment and 3-month follow-up, with the STAGE-12 condition having higher sponsorship rates. Twelve-step meeting attendance and literature reading during the treatment period predicted having a sponsor at the end of treatment. Sponsorship at the end of treatment predicted a higher likelihood of abstinence from stimulant use and having no drug-related problems at follow-up. CONCLUSIONS: This study extends previous research on sponsorship, which has mostly focused on alcohol use disorders, by indicating that sponsorship is associated with positive outcomes for those seeking treatment from stimulant use disorders. It also suggests that sponsorship rates can be improved for those seeking treatment from stimulant use disorders through a short-term TSF intervention.

Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study.

BACKGROUND: More than half of all individuals with bipolar disorder have a substance abuse problem at some point in their lifetime. Patients with comorbid substance abuse disorders often are excluded from clinical trials. Thus, treatments targeting this high-risk clinical population are lacking. OBJECTIVE: To evaluate the efficacy of divalproex sodium (hereafter referred to as valproate) in decreasing alcohol use and stabilizing mood symptoms in acutely ill patients with bipolar disorder and alcoholism. DESIGN: A 24-week, double-blind, placebo-controlled, randomized parallel-group trial. SETTING: A university hospital serving as a primary catchment-area hospital and tertiary-care facility. PARTICIPANTS: Fifty-nine subjects with diagnoses of bipolar I disorder and alcohol dependence. Intervention All study subjects received treatment as usual, including lithium carbonate and psychosocial interventions, and were randomized to receive valproate or placebo. MAIN OUTCOME MEASURES: Primary alcohol use outcomes included changes in alcohol use as indicated by changes in proportion of heavy drinking days and number of drinks per heavy drinking day. Other alcohol use outcomes included proportion of any drinking days, number of drinks per drinking day, and relapse to sustained heavy drinking. Mood outcomes included changes in depressive and manic symptoms. We used the mixed model to analyze longitudinal data. The first model used time of assessment, bipolar subtype (mixed, manic, or depressed), and treatment group (placebo or valproate) as covariates. The second nested model included the additional covariate of medication adherence. RESULTS: The valproate group had a significantly lower proportion of heavy drinking days (P = .02) and a trend toward fewer drinks per heavy drinking day (P = .055) than the placebo group. When medication adherence was added as covariate, the valproate group had significantly fewer drinks per heavy drinking day (P = .02) and fewer drinks per drinking day (P = .02). Higher valproate serum concentration significantly correlated with improved alcohol use outcomes. Manic and depressive symptoms improved equally in both groups. Level of gamma-glutamyl transpeptidase was significantly higher in the placebo group compared with the valproate group. CONCLUSIONS: Valproate therapy decreases heavy drinking in patients with comorbid bipolar disorder and alcohol dependence. The results of this study indicate the potential clinical utility of the anticonvulsant mood stabilizer, valproate, in bipolar disorder with co-occurring alcohol dependence.

Treating complicated grief and substance use disorders: a pilot study.

Empirically supported treatments for co-occurring substance use disorders (SUDs) and grief problems are lacking, despite the salience of grief pathology in substance abusers. Identification of a syndrome of complicated grief, distinct from bereavement-related depression and anxiety, led to the development of a targeted treatment, but this treatment has not been tried with persons with SUDs. We recruited 16 adults with complicated grief and substance dependence or abuse into an open pilot study of a manualized 24-session treatment, incorporating motivational interviewing and emotion coping and communication skills into our efficacious complicated grief treatment. Completer and intent-to-treat analyses showed significant reductions in Inventory of Complicated Grief and Beck Depression Inventory scores, with large effect sizes. Timeline Followback percent days abstinent increased significantly in both analyses, with medium to large effect sizes, and cravings declined significantly. Study limitations notwithstanding, complicated grief and substance use treatment appears to be a promising intervention that merits further research.

Validation of the alcohol use item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS).

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) includes five item banks for alcohol use. There are limited data, however, regarding their validity (e.g., convergent validity, responsiveness to change). To provide such data, we conducted a prospective study with 225 outpatients being treated for substance abuse. METHODS: Assessments were completed shortly after intake and at 1-month and 3-month follow-ups. The alcohol item banks were administered as computerized adaptive tests (CATs). Fourteen CATs and one six-item short form were also administered from eight other PROMIS domains to generate a comprehensive health status profile. After modeling treatment outcome for the sample as a whole, correlates of outcome from the PROMIS health status profile were examined. RESULTS: For convergent validity, the largest correlation emerged between the PROMIS alcohol use score and the Alcohol Use Disorders Identification Test (r=.79 at intake). Regarding treatment outcome, there were modest changes across the target problem of alcohol use and other domains of the PROMIS health status profile. However, significant heterogeneity was found in initial severity of drinking and in rates of change for both abstinence and severity of drinking during follow-up. This heterogeneity was associated with demographic (e.g., gender) and health-profile (e.g., emotional support, social participation) variables. CONCLUSIONS: The results demonstrated the validity of PROMIS CATs, which require only 4-6 items in each domain. This efficiency makes it feasible to use a comprehensive health status profile within the substance use treatment setting, providing important prognostic information regarding abstinence and severity of drinking.

Risk and resistance perspectives in translation-oriented etiology research.

Risk for a disorder and the mechanisms that determine its elevation, risk factors, are the focus of medical research. Targeting risk factors should serve the goal of prevention and treatment intervention. Risk, however, is but one of the aspects of liability to a disorder, a latent trait that encompasses effects of all factors leading to or from the diagnostic threshold. The coequal but opposite aspect of liability is resistance to a disorder. The factors that increase resistance and thus enable prevention or recovery may differ from those that elevate risk. Accordingly, there are nontrivial differences between research perspectives that focus on risk and on resistance. This article shows how this distinction translates into goals and methods of research and practice, from the choice of potential mechanisms tested to the results sought in intervention. The resistance concept also differs from those of "resilience" and "protective factors," subsuming but not limited to them. The implications of the concept are discussed using substance use disorder as an example and substantiate the need for biomedical research and its translation to shift to the resistance perspective.

Reduction of opioid-withdrawal symptoms with quetiapine.

OBJECTIVE: To determine the utility of quetiapine in a population undergoing ambulatory detoxification from opioids. METHOD: Medications utilized in our outpatient clinic for opioid withdrawal were evaluated for quality-assurance purposes. The treatment regimen generally included clonidine, hydroxyzine, trazodone, diphenoxylate/atropine, and sometimes chlordiazepoxide. Patients were also initially given eight 25-mg tablets of quetiapine and instructed to take 1 or 2 tablets every 4 hours as needed for symptoms of withdrawal or craving (with a maximum daily dose of 200 mg). Data were based on patient evaluations from June 2003 to June 2004. RESULTS: 41% of all patients (N = 213) successfully completed the detoxification phase of the program (i.e., completed at least 5 days of abstinence). A medication questionnaire was instituted for quality-assurance purposes after some apparent initial success with quetiapine. A retrospective analysis of these data revealed that, of the 107 patients evaluated for medication response, 79 reported that quetiapine helped reduce craving for opioids, 52 reported that quetiapine helped reduce their anxiety, 24 reported a reduction in somatic pain, 22 reported that quetiapine helped alleviate insomnia, and 14 reported an improved appetite. Four individuals did not feel quetiapine had any benefit, and another 7 were unable to tolerate quetiapine because of side effects. The quetiapine dose used ranged from 25 to 600 mg/day (mean +/- SD dose = 206 +/- 122 mg/day). CONCLUSIONS: Quetiapine use during opioid cessation was found to help abate symptoms of opioid withdrawal in our patient population and was generally well tolerated.

Patient characteristics and treatment implications of marijuana abuse among bipolar alcoholics: results from a double blind, placebo-controlled study.

OBJECTIVE: Marijuana abuse, primarily a disorder of adolescents and young adults, is highly prevalent among patients with severely ill psychiatric population, especially those with bipolar disorder. Additional marijuana abuse may impact on the clinical presentation of bipolar illness and may potentially act as mediator of treatment response in this population. However, the characterization of bipolar disorder patients with additional marijuana abuse and the impact of such abuse on treatment outcome has been rarely examined. The aim of this study was to characterize bipolar alcoholic patients with comorbid marijuana abuse and test the impact of marijuana abuse on alcohol and mood outcome of patients with bipolar disorder and comorbid alcohol dependence. METHOD: We conducted secondary analyses of a randomized, double blind, placebo-controlled trial testing valproate in 52 bipolar alcoholics. Subjects had a comprehensive assessment at baseline using structured diagnostic assessments, and they were then assessed every 2 weeks for 24 weeks. RESULTS: Twenty-five subjects (48%) reported marijuana abuse. Those with co-occurring marijuana abuse were younger, had fewer years of education, and had significantly higher number of additional psychiatric comorbidity. They also had more severe alcohol and other drug use and were significantly more likely to present in the manic phase. The mixed model indicated that the placebo-treated marijuana abuse group had the worst alcohol use outcome. CONCLUSIONS: Marijuana abuse among patients with bipolar disorder and alcohol dependence is associated with higher degree of severity of alcohol and other drugs of abuse and may negatively impact on alcohol treatment outcome.

Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

BACKGROUND: Two item banks for substance use were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): severity of substance use and positive appeal of substance use. METHODS: Qualitative item analysis (including focus groups, cognitive interviewing, expert review, and item revision) reduced an initial pool of more than 5300 items for substance use to 119 items included in field testing. Items were written in a first-person, past-tense format, with 5 response options reflecting frequency or severity. Both 30-day and 3-month time frames were tested. The calibration sample of 1336 respondents included 875 individuals from the general population (ascertained through an internet panel) and 461 patients from addiction treatment centers participating in the National Drug Abuse Treatment Clinical Trials Network. RESULTS: Final banks of 37 and 18 items were calibrated for severity of substance use and positive appeal of substance use, respectively, using the two-parameter graded response model from item response theory (IRT). Initial calibrations were similar for the 30-day and 3-month time frames, and final calibrations used data combined across the time frames, making the items applicable with either interval. Seven-item static short forms were also developed from each item bank. CONCLUSIONS: Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research in both clinical and community settings.

Major depression associated with earlier alcohol relapse in treated teens with AUD.

This study evaluated whether the common comorbid diagnosis of major depressive disorder (MDD) is associated with an earlier relapse to alcohol use among adolescents with an alcohol use disorder (AUD). The study sample consisted of 116 adolescents between the ages of 14 and 18 with an AUD recruited from treatment facilities in the Pittsburgh area, 50 of whom demonstrated a current MDD. An extensive baseline interview was conducted, followed by monthly interviews of alcohol use conducted by telephone for the following year. Those with current comorbid MDD demonstrated a median survival time of only 19 days until the first drink, while those without MDD demonstrated a median survival time of 45 days, which was a significant difference (Kaplan-Meier survival analysis, Breslow Test Statistic=4.27, df=1, P=.039). These results suggest that the comorbid presence of MDD is associated with an earlier relapse to alcohol use among adolescents with an AUD.

Is level of exposure to a 12-step facilitation therapy associated with treatment outcome?

This study examined whether level of exposure to Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), a 12-Step facilitative therapy, is related to treatment outcome. Data were from a large National Drug Abuse Treatment Clinical Trials Network (CTN) study comparing STAGE-12 combined with treatment-as-usual (TAU) to TAU alone. These analyses include only those randomized to STAGE-12 (n=234). Assessments occurred at baseline and 30, 60, 90, and 180 days following randomization. High-exposure patients (n=158; attended at least 2 of 3 individual, and 3 of 5 group, sessions), compared to those with less exposure (n=76), demonstrated: (1) higher odds of self-reported abstinence from, and lower rates of, stimulant and non-stimulant drug use; (2) lower probabilities of stimulant-positive urines; (3) more days of attending and lower odds of not attending 12-Step meetings; (4) greater likelihood of reporting no drug problems; (5) more days of duties at meetings; and (6) more types of 12-Step activities. Many of these differences declined over time, but several were still significant by the last follow-up. Treatment and research implications are discussed.

Family and social aspects of substance use disorders and treatment.

Substance use disorders (SUDs) are associated with numerous medical, psychiatric, psychological, spiritual, economic, social, family, and legal problems, creating a significant burden for affected individuals, their families, and society. This paper focuses on the effects of SUDs on family and social problems and emphasizes the need for clients in treatment to address these domains in their ongoing recovery. Individual, group, and family interventions to address these issues for clients with SUDs and their families are reviewed.

Integrated treatment of substance use and psychiatric disorders.

Epidemiological studies find that psychiatric disorders, including mental disorders and substance use disorders, are common among adults and highly comorbid. Integrated treatment refers to the focus of treatment on two or more conditions and to the use of multiple treatments such as the combination of psychotherapy and pharmacotherapy. Integrated treatment for comorbidity has been found to be consistently superior compared to treatment of individual disorders with separate treatment plans. This article focuses on a review of the risks for developing comorbid disorders and the combinations of treatments that appear to be most effective for clients with particular comorbid disorders.

12-step interventions and mutual support programs for substance use disorders: an overview.

Social workers and other behavioral health professionals are likely to encounter individuals with substance use disorders in a variety of practice settings outside of specialty treatment. 12-Step mutual support programs represent readily available, no cost community-based resources for such individuals; however, practitioners are often unfamiliar with such programs. The present article provides a brief overview of 12-Step programs, the positive substance use and psychosocial outcomes associated with active 12-Step involvement, and approaches ranging from ones that can be utilized by social workers in any practice setting to those developed for specialty treatment programs to facilitate engagement in 12-Step meetings and recovery activities. The goal is to familiarize social workers with 12-Step approaches so that they are better able to make informed referrals that match clients to mutual support groups that best meet the individual's needs and maximize the likelihood of engagement and positive outcomes.