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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00713583 |
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 positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. We have observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups.
Potential treatment predictors related to reward saliency and motivation will be assessed before and during treatment. We will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.
Condition | Intervention | Phase |
---|---|---|
Cocaine Dependence |
Drug: levodopa Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Contingency Management Plus Levodopa/Carbidopa for Treatment of Cocaine Dependence |
Estimated Enrollment: | 160 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Levodopa pharmacotherapy
|
Drug: levodopa
800/200 mg/d levodopa carbidopa
|
2: Experimental
Placebo
|
Drug: Placebo
Placebo
|
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan A Lindsay, Ph.D. | 7135002563 | jan.a.lindsay@uth.tmc.edu |
Contact: Shems A Nabelsi, B.S. | 7135002800 | shems.nabelsi@uth.tmc.edu |
United States, Texas | |
Mental Sciences Institute | Recruiting |
Houston, Texas, United States, 77030 | |
Sub-Investigator: Frederick G Moeller, M.D. |
Principal Investigator: | Joy M Schmitz, Ph.D. | University of Texas at Houston |
Responsible Party: | University of Texas Medical School at Houston ( Joy Schmitz, Ph.D. ) |
Study ID Numbers: | 1R01DA023608-01, 1R01DA023608-01, DPMCDA |
Study First Received: | July 9, 2008 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00713583 History of Changes |
Health Authority: | United States: Federal Government |
Cocaine, levodopa, contingency management |
Dopamine Uptake Inhibitors Cocaine-Related Disorders Levodopa Neurotransmitter Agents Carbidopa Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Cardiovascular Agents |
Anesthetics, Local Dopamine Mental Disorders Sinemet Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Disorders of Environmental Origin Anesthetics Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders |
Vasoconstrictor Agents Cocaine Cocaine-Related Disorders Levodopa Carbidopa Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Anesthetics, Local Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |