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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 2011 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirmed abstinence from cocaine | 12 weeks of treatment | No |
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