Measures of outcome for stimulant trials: ACTTION recommendations and research agenda

BACKGROUND: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. METHODS: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. RESULTS AND CONCLUSIONS: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success

Efficacy of cognitive behavioral therapy for alcohol and other drug use disorders: is a one-size-fits-all approach appropriate?

PURPOSE: We provide an overview of Cognitive Behavioral Therapy (CBT) efficacy for adult alcohol or other drug use disorders (AOD) and consider some key variations in application as well as contextual (ie, moderators) or mechanistic (ie, mediators) factors related to intervention outcomes. METHODS: This work is a narrative overview of the review literature on CBT for AOD. RESULTS: Robust evidence suggests the efficacy of classical/traditional CBT compared to minimal and usual care control conditions. CBT combined with another evidence-based treatment such as Motivational Interviewing, Contingency Management, or pharmacotherapy is also efficacious compared to minimal and usual care control conditions, but no form of CBT consistently demonstrates efficacy compared to other empirically-supported modalities. CBT and integrative forms of CBT have potential for flexible application such as use in a digital format. Data on mechanisms of action, however, are quite limited and this is despite preliminary evidence that shows that CBT effect sizes on mechanistic outcomes (ie, secondary measures of psychosocial adjustment) are moderate and typically larger than those for AOD use. CONCLUSION: CBT for AOD is a well-established intervention with demonstrated efficacy, effect sizes are in the small-to-moderate range, and there is potential for tailoring given the modular format of the intervention. Future work should consider mechanisms of CBT efficacy and key conditions for dissemination and implementation with fidelity