Buprenorphine treatment for opioid use disorder: recent progress.

Introduction: Opioid use disorder (OUD) has risen globally and is exerting an enormous toll on public health in many countries, particularly in the United States (US). Buprenorphine (BUP) has become one of the mainstays of pharmacological treatment for OUD and newer delivery methods have been developed to improve its effectiveness in treatment. Areas covered: We provide a review of BUP products available for OUD, with a focus on the newer long-acting formulations. A literature search was conducted using PubMed, Google Scholar, and ClinicalTrials.gov to find randomized clinical trials of long-acting BUP products. Four randomized clinical trials were found: two with BUP implant and two with subcutaneous injectable BUP. Expert opinion: In these clinical trials, new BUP formulations were found to be non-inferior to sublingual (SL) BUP and more effective than placebo in reducing opioid use. Longer-acting formulations can improve flexibility in dosing but superiority over existing SL BUP with regards to outcomes needs to be ascertained. There is a need for more comparative studies between longer-acting BUP formulations and currently available SL BUP. Future studies should also include other clinically meaningful outcomes such as quality of life measures, long-term remission rates, and cost-effectiveness.

The Effectiveness and Cost of Clinical Supervision for Motivational Interviewing: A Randomized Controlled Trial.

The effectiveness of a competency-based supervision approach called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP) was compared to supervision-as-usual (SAU) for increasing clinicians' motivational interviewing (MI) adherence and competence and client retention and primary substance abstinence in a multisite hybrid type 2 effectiveness-implementation randomized controlled trial. Participants were 66 clinicians and 450 clients within one of eleven outpatient substance abuse programs. An independent evaluation of audio recorded supervision sessions indicated that MIA: STEP and SAU were highly and comparably discriminable across sites. While clinicians in both supervision conditions improved their MI performance, clinician supervised with MIA: STEP, compared to those in SAU, showed significantly greater increases in the competency in which they used fundamental and advanced MI strategies when using MI across seven intakes through a 16-week follow-up. There were no retention or substance use differences among the clients seen by clinicians in MIA: STEP or SAU. MIA: STEP was substantially more expensive to deliver than SAU. Innovative alternatives to resource-intensive competency-based supervision approaches such as MIA: STEP are needed to promote the implementation of evidence-based practices.

Assessment concordance and predictive validity of self-report and biological assay of cocaine use in treatment trials.

BACKGROUND AND OBJECTIVES: Cocaine use during randomized clinical trials (RCTs) is typically assessed by participant self-report or biological assay (eg, urinalysis). There have been few direct comparisons of these assessment methods to investigate their concordance and their predictive validity for cocaine use and psychosocial outcomes following treatment completion. METHOD: In a combined sample of 380 participants from 5 cocaine RCTs, the concordance between cocaine use assessment methods was examined. Sequential multiple linear and logistic regression models evaluated the predictive validity of two assessment methods for cocaine use and psychosocial outcomes assessed at 1, 3, 6, and 12 months after treatment. RESULTS: Concordance for self-report and urinalysis indicators of cocaine use was high within-treatment (k = 0.72) and moderate during follow-up (k = 0.51). Rates of concordance were higher in studies using test cups with immediate urinalysis results. Regression analyses indicated that self-report data within-treatment predicted self-reported cocaine use at all post-treatment points (ß 0.22-0.30, p < .01), while urinalysis results within-treatment predicted urinalysis results at 1, 3, and 6 months post-treatment (OR 3.92-20.99, p < .05). Cocaine-positive urinalyses within-treatment were negatively associated with a composite "good outcome" indicator at 1 and 3 months post-treatment (OR 0.17-0.32, p < .05). DISCUSSION AND CONCLUSIONS: These results suggest a significant role of method variance in predicting post-treatment outcomes from within-treatment cocaine use indices. SCIENTIFIC SIGNIFICANCE: Results support recommendations that cocaine treatment trials should include both biological assay and self-report assessment. Test cups may facilitate increased self-report accuracy.

Technology-based interventions for the treatment and recovery management of substance use disorders: a JSAT special issue.

A growing line of research has highlighted the promising role that interactive web and mobile technologies may play in improving the effectiveness, cost-effectiveness, and reach of efforts to assess, prevent, treat, and support the recovery management of substance use disorders and other risk behavior. Manuscripts in this special issue of the Journal of Substance Abuse Treatment focus on the application of technology to the delivery of interventions for the treatment and recovery management of substance use disorders. These manuscripts are intended to highlight the diversity and current state of the science of empirically-supported innovations in this area of intervention delivery. The included manuscripts range from experimental evaluations of a variety of types of technology-based interventions (brief interventions, behavior therapy, medication adherence tools, and HIV prevention interventions) and technology platforms (mobile, Web, videoconferencing, and telephone-based interactive voice response), for an array of populations (adults, adolescents, criminal justice populations, and post-partum women), in a number of different settings (addiction specialty treatment programs, schools, emergency rooms, and criminal justice settings). They additionally reflect a variety of experimental research designs, including those focused on the design, development, and clinical evaluation of these technology-based therapeutic tools, as well as research focused on models for their successful implementation and sustained use.

New developments in behavioral treatments for substance use disorders.

After decades of defining which behavioral treatments are effective for treating addictions, the focus has shifted to exploring how these treatments work, how best to disseminate and implement them in the community, and what underlying factors can be manipulated in order to increase the rates of treatment success. These pursuits have led to advances in our understanding of the mechanisms of treatment effects, the incorporation of technology into the delivery of current treatments and development of novel applications to support relapse prevention, as well as the inclusion of neurocognitive approaches to target the automatic and higher-order processes underlying addictive behaviors. Although such advances have the promise of leading to better treatments for more individuals, there is still much work required for these promises to be realized. The following review will highlight some of these recent developments and provide a glimpse into the future of behavioral treatments.

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.

Cost and cost-effectiveness of three strategies for training clinicians in motivational interviewing.

OBJECTIVE: To evaluate the cost and cost-effectiveness of three strategies for teaching community program clinicians motivational interviewing (MI): self-study (SS), expert-led (EX), and train-the-trainer (TT). METHODS: This economic analysis was conducted as part of a three-arm clinician training trial comprising 12 community treatment programs randomly assigned to the three conditions (n=92 clinician participants). EX and TT conditions used skill-building workshops and three monthly supervision sessions. SS provided clinicians MI training materials only. The primary outcome measure was the number of clinicians meeting MI performance standards at 12-week follow-up. Unit costs were obtained via surveys administered at the 12 participating programs. Resource utilizations and clinician outcomes were obtained from the training trial. Costs and outcomes were normalized to account for differing numbers of clinicians across programs and conditions. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were used to evaluate the relative cost-effectiveness of the three training strategies. RESULTS: SS is likely to be the most cost-effective training strategy if the threshold value to decision makers of an additional clinician meeting MI performance standards at 12-week follow-up is less than approximately $2870, and EX is likely to be the most cost-effective strategy when the threshold value is greater than approximately $2870. CONCLUSIONS: This study provides accurate estimates of the economic costs and relative cost-effectiveness of three different strategies for training community program clinicians in motivational interviewing and should be of interest to decision makers seeking to implement empirically supported addiction treatments with scarce resources.

Community program therapist adherence and competence in a motivational interviewing assessment intake session.

BACKGROUND: Teaching community program therapists to use motivational interviewing (MI) strategies for addictions treatment with sufficient frequency (i.e., adherence) and skill (i.e., competence) is a priority and challenge for the field. The development of psychometrically valid MI integrity measures that can be used for supervision and evaluation and be both sensitive and robust across clinical situations is needed. OBJECTIVE: This article examines the performance of the Independent Tape Rating Scale (ITRS) when used to evaluate the delivery of MI within a one-session assessment intake. METHODS: Audiotapes of 315 sessions of therapists in MI and counseling-as-usual conditions were rated according to the ITRS by raters blind to treatment condition. RESULTS: Results indicate that community therapists were successfully trained and supervised to use MI within an assessment intake session, with MI adherence and competence that was discriminable from counseling-as-usual practices. Increased therapist MI adherence and competence was associated with increases in an index of client motivation for change, though unrelated to treatment outcome. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: The ITRS appears to be a valid instrument for measuring therapist MI adherence and competence within an assessment intake.

Cost-effectiveness of computer-assisted training in cognitive-behavioral therapy as an adjunct to standard care for addiction.

AIM: To determine the cost-effectiveness, from clinic and patient perspectives, of a computer-based version of cognitive-behavioral therapy (CBT4CBT) as an addition to regular clinical practice for substance dependence. PARTICIPANTS, DESIGN AND MEASUREMENTS: This cost-effectiveness study is based on a randomized clinical trial in which 77 individuals seeking treatment for substance dependence at an outpatient community setting were randomly assigned to treatment as usual (TAU) or TAU plus biweekly access to computer-based training in CBT (TAU plus CBT4CBT). The primary patient outcome measure was the total number of drug-free specimens provided during treatment. Incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves (CEACs) were used to determine the cost-effectiveness of TAU plus CBT4CBT relative to TAU alone. Results are presented from both the clinic and patient perspectives and are shown to be robust to (i) sensitivity analyses and (ii) a secondary objective patient outcome measure. FINDINGS: The per patient cost of adding CBT4CBT to standard care was $39 ($27) from the clinic (patient) perspective. From the clinic (patient) perspective, TAU plus CBT4CBT is likely to be cost-effective when the threshold value to decision makers of an additional drug-free specimen is greater than approximately $21 ($15), and TAU alone is likely to be cost-effective when the threshold value is less than approximately $21 ($15). The ICERs for TAU plus CBT4CBT also compare favorably to ICERs reported elsewhere for other empirically validated therapies, including contingency management. CONCLUSIONS: TAU plus CBT4CBT appears to be a good value from both the clinic and patient perspectives.

A randomized controlled trial of a money management-based substance use intervention.

OBJECTIVE: Money management has been implemented, often in bundled interventions, as a strategy to counteract spending of public support checks and other funds on drugs and alcohol. The authors conducted a randomized controlled trial of a voluntary money management program as an adjunctive treatment for patients in treatment for mental illness, substance use disorders, or both. In the advisor-teller money manager (ATM) intervention, a money manager stores patients' checkbooks and automated bank cards, trains patients to manage their own funds, and links spending to activities related to their treatment goals. METHODS: Eighty-five veterans with recent use of alcohol or cocaine were randomly assigned to 36 weeks of the ATM intervention or a control intervention (completion of a simple financial workbook). RESULTS: With ATM, 75% of veterans gave their checkbook to their money manager to hold, and participants attended significantly more therapy sessions than those assigned to the control therapy (mean of 20.6 versus 8.1 sessions). Although participants assigned to ATM did not show significantly greater improvement over time on the primary outcomes (self-reported abstinence from alcohol and cocaine and negative urine tests for cocaine metabolite), they reduced their Addiction Severity Index drug and alcohol use composite scale scores more rapidly than the control group. High rates of abstinence in both groups created a ceiling effect, limiting the power to detect improved abstinence rates. CONCLUSIONS: In this relatively small trial, ATM, a money management intervention, showed promise in engaging patients, improving their money management, and improving some substance abuse outcomes.

The cost-effectiveness of four treatments for marijuana dependence.

AIM: To analyze data from a randomized clinical trial to determine the cost-effectiveness of using contingency management (CM) and motivational/skills building therapy (motivational enhancement therapy/cognitive-behavioral therapy: MET/CBT) to treat young adults with marijuana dependence. PARTICIPANTS, DESIGN AND MEASUREMENTS: A total of 136 marijuana-dependent young adults, all referred by the criminal justice system, were randomized to one of four treatment conditions: MET/CBT with CM, MET/CBT without CM, drug counseling (DC) with CM and DC without CM. Patient outcome measures include the longest duration of confirmed marijuana abstinence (LDA) during treatment and the total number of marijuana-free urine specimens provided during treatment. Costs were collected retrospectively from the provider and include the costs of therapy, patient drug testing, and those associated with the incentives component (value of vouchers, time to administer the voucher system). SETTING: Out-patient substance abuse clinic in New Haven, Connecticut, USA. FINDINGS: Which treatment is the most cost-effective depends on the threshold values of an additional week of LDA or an additional marijuana-free urine specimen. For example, the most effective treatment, MET/CBT with CM, was also the most cost-effective treatment at the highest threshold values, while the least effective treatment, DC, was the most cost-effective at the lowest values. Because consensus threshold values for these patient outcomes do not exist, results are presented showing the ranges of values over which each treatment would be considered cost-effective compared to the others. Acceptability curves are presented to show the decision uncertainty associated with these ranges. The results are shown to be robust to (i) sensitivity analyses on several key cost parameters and (ii) patient outcomes measured during the 6-month follow-up period. CONCLUSIONS: This study uses incremental cost-effectiveness ratios and acceptability curves to shed light on the relative cost-effectiveness of four interventions for treating young adults with marijuana dependence. Given the relatively small and specialized nature of our study sample, and the fact that we examined a CM procedure with a single reinforcement schedule, additional studies are warranted to determine the reliability and generalizability of our results both to alternative marijuana-using populations and to CM procedures with alternative incentive parameters. Nevertheless, the relative durability of effects of MET/CBT compared to DC through the 6-month follow-up, and its cost-effectiveness over a comparatively wide range of threshold values, underscores the promise of this approach.

We don't train in vain: a dissemination trial of three strategies of training clinicians in cognitive-behavioral therapy.

There has been little research on the effectiveness of different training strategies or the impact of exposure to treatment manuals alone on clinicians' ability to effectively implement empirically supported therapies. Seventy-eight community-based clinicians were assigned to 1 of 3 training conditions: review of a cognitive-behavioral therapy (CBT) manual only, review of the manual plus access to a CBT training Web site, or review of the manual plus a didactic seminar followed by supervised casework. The primary outcome measure was the clinicians' ability to demonstrate key CBT interventions, as assessed by independent ratings of structured role plays. Statistically significant differences favoring the seminar plus supervision over the manual only condition were found for adherence and skill ratings for 2 of the 3 role plays, with intermediate scores for the Web condition.

Choosing a behavioral therapy platform for pharmacotherapy of substance users.

Behavioral therapy platforms have become virtual requirements in pharmacotherapy trials due to their utility in reducing noise variability, preventing differential medication adherence and protocol attrition, enhancing statistical power and addressing ethical issues in placebo-controlled trials. Selecting an appropriate behavioral platform for a particular trial requires study-specific tailoring, taking into account both the stage of development of the medication being evaluated, as well as the specific strengths and weaknesses of a broad array of available empirically supported behavioral therapies and the range of their possible targets (e.g., enhancing medication adherence, preventing attrition, addressing co-morbid problems, fostering abstinence, and targeting specific weaknesses of the pharmacologic agent). Choosing a suitable behavioral platform also requires consideration of the characteristics of the population to be treated, stage of scientific knowledge regarding the medication's effects, appropriate balance of internal and external validity, and consideration of potential ceiling effects. Available manualized behavioral treatments are reviewed, noting their strengths and limitations as behavioral therapy platforms for pharmacotherapy trials and as potential concomitant therapies in clinical practice.

Cost effectiveness of disulfiram: treating cocaine use in methadone-maintained patients.

Converging evidence suggests that disulfiram is a promising treatment for cocaine dependence. We study the cost-effectiveness of providing disulfiram to methadone-maintained opioid addicts in a randomized clinical trial setting. Our economic evaluation is based on a double blind clinical trial in which 67 cocaine-dependent methadone-maintained opioid-dependent subjects were randomized to get the additional treatment of disulfiram or placebo in a 12-week trial. Outcome measures used are the number of days of cocaine use and grams of cocaine per week. Cost measures used are the cost of providing standard methadone treatment and the incremental cost of adding disulfiram to the standard treatment. Cost measures of standard and disulfiram-enhanced treatment were collected retrospectively from the provider. Results from this cost-effectiveness analysis imply that, even though disulfiram increases slightly the cost of methadone treatment, its increase in effectiveness may be important enough to warrant its addition for treating cocaine dependence in methadone-maintained opiate addicts.

Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom?

AIMS: This study evaluated the efficacy of a low-cost, prize reinforcement contingency management (CM) intervention for reducing cocaine use. SETTING: Community-based treatment centers. PARTICIPANTS AND DESIGN: Cocaine-abusing out-patients (n = 120) were assigned randomly to one of three 12-week conditions: standard treatment, standard treatment plus CM with an expected maximum of $80 of reinforcement or standard treatment plus CM with an expected maximum of $240 of reinforcement. INTERVENTION: In the CM conditions, patients earned the opportunity to win prizes for submitting negative urine samples and completing goal-related activities. MEASUREMENTS: Drug use was measured at intake and throughout a 3-month treatment period. FINDINGS: Patients in the $240 CM condition achieved more abstinence than patients in the standard condition. Patients who initiated treatment with positive urinalysis results were most responsive to the CM intervention, with the $240 CM condition engendering the best effects in this subgroup. In contrast, patients who initiated treatment with negative urinalysis results generally remained abstinent during treatment, regardless of treatment assignment. On average, patients in the two CM conditions earned $36 and $68 in prizes. CONCLUSIONS: This study suggests that prize reinforcement CM may be suitable for community-based settings, and beneficial effects may be magnitude-dependent in more severe patients.

Bridging the gap: a hybrid model to link efficacy and effectiveness research in substance abuse treatment.

Many behavioral and pharmacologic treatments for which there is strong empirical support are rarely used in clinical practice in the treatment of substance dependence. In an effort to facilitate greater emphasis on issues such as utility, practicality, and cost earlier in the evaluation of promising therapies, the authors propose a hybrid model to link efficacy and effectiveness research. A hybrid model may foster broader use of empirically validated treatments in substance abuse treatment programs and enhance the scientific yield of effectiveness research. The hybrid model retains essential features of efficacy research (randomization, use of control conditions, independent assessment of outcome, and monitoring of treatment delivery) while expanding the research questions to also address issues of importance in effectiveness studies. Such issues include diversity in settings, clinicians, and patients; cost-effectiveness of treatment; training issues; and patient and clinician satisfaction.