Cocaine-Related Disorders Clinical Trial
Official title:
Screening Medications for Cocaine Cessation and Relapse Prevention
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.
Cocaine is a strong central nervous system stimulant that is widely abused throughout the
United Sates. Due to its widespread use, it is important to develop an effective treatment
for cocaine dependence. Motivational Interviewing (MI) is often effective when combined with
drug treatment. Baseline condition (e.g., abstinence status) and population type (e.g.,
ethnicity and gender) often affect how an individual responds to treatment for drug
dependence. The purpose of this study is to determine the influence of baseline status and
population type on treatment response in cocaine dependent individuals. In addition, this
study will examine how various cocaine abuse medications target different neuronal systems,
withdrawal symptoms, and relapse to drug use.
This study will take place in two phases. Phase I will last 4 weeks; participants will
receive MI and undergo contingency-based urine tests in order to achieve the desired
baseline condition. Phase II will last 12 weeks. Participants in Phase II will be randomly
assigned to receive one of four treatments: 1) 50 mg naltrexone, 2) 800/200 mg
levodopa/carbidopa, 3) 400 mg modafinil, or 4) placebo. During Phase II, all participants
will receive psychotherapy and contingency management. Participants will complete urine drug
screening tests 3 times each week. Follow-up study visits will occur between 3 and 6 months
following Week 12, and will include objective and self-reported drug use.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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