Fluoxetine, by acting on the serotonin system in the brain, may treat cocaine dependence. In order to increase outpatient volunteers'''' compliance with taking fluoxetine, this study enrolls methdone-maintained heroin and cocaine abusers who already visit a methadone clinic daily. In addition to fluoxetine treatment, volunteers also participate in an incentive-based voucher program.

Condition	Intervention
Fluoxetine	Drug: Fluoxetine

Further Study Details: 

Primary Outcomes: Side effects; Cocaine use
Expected Total Enrollment:  220

This is a clinical trial testing the efficacy of fluoxetine versus placebo in the outpatient treatment of cocaine dependence. Participants have concurrent opioid dependence and are treated with methadone, which ensures compliance in taking the fluoxetine. Patients are also randomized to voucher incentives versus no vouchers, so the interactive effects of motivation to stop cocaine use can also be studied. Finally, based upon other studies a dose of fluoxetine is selected to maximize the likelihood of response. The study hypothesis is that fluoxetine will exert a mild beneficial effect on cocaine use, and this effect will be enhanced through the inclusion of motivation (i.e., the voucher incentive program). Participants are opioid and cocaine dependent outpatient volunteers enrolled in a treatment-research clinic for a thirty-three week study period.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Evidence of active opioid dependence
• Qualify for methadone maintenance treatment
• Evidence of concurrent cocaine dependence

Exclusion Criteria:

• Significant medical or psychiatric illnesses
• Current treatment with a specific serotonin reuptake inhibitor (SSRI)
• History of allergy to SSRI medications

Maryland
      Johns Hopkins University School of Medicine, Baltimore,  Maryland,  21224,  United States

Study chairs or principal investigators

Eric C Strain, M.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIDA-10754-2; R01-10754-2
Last Updated:  September 9, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142779
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13