Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts

Opioid-Related Disorders Clinical Trial

Official title:

Serotonin Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142779
• Other study ID #: NIDA-10754-2
• Secondary ID: R01-10754-2DPMC
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: January 11, 2017
• Start date: April 2001
• Est. completion date: March 2006

Study information

• Verified date: May 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently receiving methadone treatment.

Description:

Individuals addicted to cocaine often experience feelings of restlessness, irritability, anxiety, and paranoia. Reducing cocaine use can lead to depression. In an attempt to alleviate the depressive symptoms, individuals may resume drug use. Fluoxetine, a medication that is currently used to treat depression and panic attacks, may assist at reducing cocaine use in individuals addicted to cocaine. By increasing serotonin, a chemical in the brain that helps maintain mental balance, fluoxetine may lessen depressive symptoms and decrease the reinforcing effects of cocaine. Voucher incentive programs, in which items or services are offered as a reward for remaining drug-free, are also a useful component of substance abuse treatment. Preliminary research has shown that fluoxetine, when combined with an incentive program, is an effective treatment for reducing cocaine use. Further research is needed to confirm the benefits of fluoxetine for cocaine and opioid addicts. The purpose of this study is to evaluate the effectiveness of fluoxetine, in combination with a voucher incentive program, at reducing cocaine use in methadone-maintained cocaine and opioid addicts.

This 33-week study will enroll individuals addicted to both cocaine and opioids who are concurrently enrolled in a methadone treatment program. Participants will be randomly assigned to receive either 60 mg of fluoxetine or placebo on a daily basis for 12 weeks from Weeks 8 through 19. Study visits will occur once a week. Questionnaires and self-reports will be completed to assess medication side effects and cocaine use. Cocaine levels will be monitored three times a week with urine tests. During the 12 weeks of treatment, participants will also be randomly assigned to either take part in a voucher incentives program or not take part in the program. Participants in the voucher program will receive a voucher that may be exchanged for various items and services for each urine test with a negative cocaine result.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Currently dependent on opioids

• Currently dependent on cocaine

• Eligible to receive methadone maintenance treatment

Exclusion Criteria:

• Current significant medical or psychiatric illness

• Current use of a specific serotonin reuptake inhibitor (SSRI)

• History of allergy to SSRI medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Opioid-Related Disorders

Intervention

Drug:
• Fluoxetine

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine use (measured by urine screen and self-report at Week 19 and 33)
Primary	Medication side effects (measured by self-reports throughout Weeks 8 through 19)