NIDA Clinical Trials Network
4/1/09 - 9/30/12
Edward Nunes, MD
Other Project Staff
Aimee Campbell, PhD (Project Director), Lisa A. Marsch, PhD (Advisor)
The principal objective of this trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA) intervention (the Therapeutic Education System [TES]) plus incentives targeting drug abstinence and treatment participation as part of community-based, outpatient substance abuse treatment.
Individuals accepted in outpatient treatment for substance use disorders (excluding those receiving opioid pharmacotherapy for opioid dependence) will be eligible to participate. We will conduct a multi-site, controlled trial, using NIDA’s Clinical Trials Network (CTN) platform, at approximately 10 Community Treatment Programs (CTPs), in which participants (n = approximately 500) are randomized to receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating CTPs in which participants are enrolled, or (2) a modification of TAU which includes access to the Therapeutic Education System (TES), a computerized psychosocial intervention which combines skills building modules based on the Community Reinforcement Approach (CRA) with incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules. We will evaluate the relative effectiveness of these interventions on the primary outcome measures of (a) drug abstinence during active treatment (measured as the total number of weeks abstinent from all tested drugs of abuse and heavy drinking days during the 12 weeks of treatment via self-report using the TimeLine Follow-Back procedure and urine testing and (b) treatment retention.
We will also evaluate the relative effectiveness of these interventions on several secondary outcome measures, including (a) HIV risk behavior (measured via the Risk Behavior Survey), (b) psychosocial functioning (in areas of criminal activity, health status improvement, psychological status, family/social relationships, and employment, as measured via the SAS-SR, Non-study Medical and Other Services (NSMS), and BSI) and (c) treatment acceptability (based on participant feedback). Additionally, we will evaluate outcomes at 3- and 6-month post-intervention follow-ups. As an additional secondary analysis, we will perform a comprehensive economic analysis of including TES with TAU to inform decisions regarding adoption of this new therapeutic tool (assessing incremental costs per increased abstinence time and quality adjusted life year, measured via modified versions of the EuroQol EQ5D, NSMS and Program DATCAP). The economic analyses are clinically important, as even if the computerized intervention is shown to be effective, it may have limited adoption within community-based treatment programs unless it is also shown to be cost-effective.
Public Health Relevance
Overall, the proposed research will contribute new empirical information relevant to increasing the delivery of science-based psychosocial treatment with fidelity in CTPs in a manner that may be cost-effective and which may promote the adoption of effective treatment. TES provides a comprehensive, science-based, psychosocial treatment from an automated web-based platform with high potential for dissemination. TES, and similar interventions, if found effective, could substantially advance the substance abuse treatment system by improving quality of care delivered, increasing availability of treatment slots by extending and leveraging the efforts of clinical staff, and projecting treatment to rural and other underserved areas.
Note: CTBH Director, Dr. Marsch, is affiliated with the small business that developed and licenses TES. This relationship is managed by her academic institution.