At a glance
ClinicalIndex Comparison Record- ✓Meets DSM-IV criteria for current cocaine dependence
- ✕Serious psychiatric symptoms or disorders that would interfere with treatment (e.g., psychosis, mania, suicidal/homicidal ideation) or other drug dependence (except nicotine and cannabis)
- ✕Medical contraindications to naltrexone (e.g., opioid use in prior 30 days or significant hepatocellular injury)
- ✕Medical contraindications to modafinil (e.g., hypertension, seizures, arrhythmia, or coronary artery disease)
- ✕Medical contraindications to levodopa/carbidopa (e.g., severe pulmonary/cardiovascular disease, narrow angle glaucoma, melanoma, peptic ulcer history, or renal impairment)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Screening Medications for Cocaine Cessation and Relapse Prevention
In Brief
A Phase 2 clinical trial evaluating Modafinil, Levodopa/Carbidopa, and 5 other interventions for Cocaine Abuse and Cocaine-Related Disorders. Completed, enrolled 101 participants across 1 site.
Detailed Summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals.
Study Details
Timeline
Interventions
The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase I.
Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase I.
Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase I.
Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.
The primary goal of motivational interviewing (MI) was to assist patients in achieving initial abstinence by increasing motivation and commitment to change. The MI intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. The client-centered, MI-style sessions focused on building motivation for change, exploring ambivalence, obtaining a commitment to change, making a plan for abstinence (Session 1), providing personalized feedback, reassessing commitment for change, and reevaluating the change plan (Session 2). Masters-level therapists were trained and supervised by the therapy supervisor (ALS), an expert in motivation-based therapies.
Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during phase I) and medication compliance (during phase II).
Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. This therapy component focused on coping-skills training for resisting cocaine use in high-risk situations, based on relapse-prevention theory and manual-guided techniques. Therapy sessions were conducted by master's-level licensed professional counselors supervised by a licensed clinical psychologist, who monitored manual adherence and competency.