Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142779
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Opioid-Related Disorders Drug: Fluoxetine Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Serotonin Treatment of Cocaine Dependence
Study Start Date : April 2001
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cocaine use (measured by urine screen and self-report at Week 19 and 33)
  2. Medication side effects (measured by self-reports throughout Weeks 8 through 19)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142779

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Eric C. Strain, MD Johns Hopkins University

Responsible Party: Eric C. Strain, Johns Hopkins University School of Medicine Identifier: NCT00142779     History of Changes
Other Study ID Numbers: NIDA-10754-2
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: May 2009

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Addiction
Cocaine Dependence
Opiate Addiction
Opiate Dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors