Clinical Trial: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")
Brief Summary:
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates.
Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.
Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with Acceptance and Commitment Therapy in combination with Contingency Management, as compared to Drug Counseling in combination with Contingency Management, to prevent relapse.
Detailed Summary:
Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a growing armamentarium of evidence-based interventions, including pharmacotherapies and psychotherapies. A core principle of drug addiction treatment, however, states that no single treatment is appropriate for everyone; rather, treatments need to be adjusted based on patient characteristics and response in order to be maximally effective. Ideally, clinicians would identify a sequence of interventions that works best across different stages of addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment interventions have been used successfully to inform this sequential clinical decision-making process. For cocaine use disorders (CUD), the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures. Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by all other forms of behavioral or pharmacological treatment, making it a prototypical first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future abstinence. For the clinician, these research findings translate into a straightforward question: Can the investigators drive CM response rates even higher with targeted adjunctive interventions?
The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data needed to answer this question. First, the investigators will determine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial treatment response rates. The investigators hypothesize that four weeks of treatment with ACT+CM will produce higher abstinence rates than initial treatment combining standard Drug Counseling with CM (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of
Sponsor: The University of Texas Health Science Center, Houston
Current Primary Outcome: Cocaine Use as assessed by urine drug screen levels [ Time Frame: 12 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Cocaine Use as assessed by Timeline Follow-back [ Time Frame: 12 Weeks ]
Original Secondary Outcome: Same as current
Information By: The University of Texas Health Science Center, Houston
Dates:
Date Received: September 6, 2016
Date Started: January 2016
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016
