Medications for Stopping Cocaine Dependence and Preventing Relapse
Condition: Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Recurrence; Cocaine-Related Disorders
Intervention: Modafinil; Levodopa/Carbidopa; Naltrexone HCl; Placebo; Motivational Interviewing (MI); Contingency management (CM); Cognitive-Behavioral Therapy (CBT)
Intervention description: 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.
Intervention MeSH terms: Naltrexone; Levodopa; Carbidopa; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cocaine; cocaine addiction; cocaine abuse; relapse prevention

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for current cocaine dependence

        Exclusion Criteria:

          -  Meet diagnostic criteria for other serious psychiatric symptoms and/or disorders that
             would interfere with participation in the treatment study (e.g., psychosis; mania;
             suicidal/ homicidal ideation) including other forms of drug dependence, nicotine and
             cannabis excepted.

          -  Medical conditions contraindicating naltrexone therapy (e.g., past history of opioid
             use in the 30 days prior to study entry or significant hepatocellular injury)

          -  Medical conditions contraindicating modafinil therapy (e.g., hypertension, seizures,
             arrhythmia, or coronary artery disease)

          -  Medical conditions contraindicating levodopa/carbidopa therapy (e.g., severe
             pulmonary/cardiovascular disease, narrow angle glaucoma, melanoma, history of peptic
             ulcer, or renal function impairment)

          -  Requires certain medications

          -  Current or recent treatment for substance use or other psychiatric condition

          -  On parole or probation that requires reports of drug use to officers of the court

          -  Pending incarceration

          -  Pregnant or breastfeeding

          -  Unable to read, write, or speak English

          -  Plans to leave the study area within 3 months of study entry