Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Contingency Management Plus Levodopa/Carbidopa for Treatment of Cocaine Dependence|
- Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
800/200 mg/d levodopa carbidopa
Other Name: Sinemet
Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on reinforcement principles have shown the most robust empirical support for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug alternatives are introduced into the environment with the goal of increasing the ratio of reinforcement derived from nondrug stimuli to the ratio of drug-derived reinforcement. Cocaine dependent individuals vary in their responsiveness or sensitivity to nondrug reinforcers, however, which has been a limiting factor in the efficacy of CM interventions.
Recent lines of evidence suggest that certain medications add efficacy to CM interventions, particularly agents that target dopaminergic (DA) actions in cocaine reinforcement. A particularly promising medication that we have investigated is the DA precursor levodopa, an agent that increases the store of available central DA in DA-deficient individuals. We have observed the strongest effects of levodopa when the medication is administered in the context of CM therapy. A plausible explanation for the efficacy of this combination treatment is that levodopa, when given concomitantly with CM, enhances the saliency value of the incentives, which in turn motivates goal-directed behavior (abstinence).
The proposed study is designed to replicate, predict, and extend the effects of this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. Abstinent-based contingency management procedures will serve as the behavioral therapy platform for both treatment groups. Potential treatment predictors related to attentional bias and motivation will be assessed at baseline and during treatment. We hypothesize that CM+levodopa will be more effective than CM+placebo in reducing cocaine use and that the effects of CM+levodopa will be significantly associated with levels of attentional bias and motivation at pretreatment and during treatment. Finally, we expect to demonstrate that continued levodopa treatment (versus placebo) following discontinuation of CM extends abstinence duration.
This study is expected to validate the usefulness of a novel behavioral-pharmacological treatment and in doing so, shed light on the mechanisms underlying the synergism between DA augmentation strategies and reinforcement-based therapies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713583
|Principal Investigator:||Joy M Schmitz, Ph.D.||University of Texas at Houston|