Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00142779
First received: September 1, 2005
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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 Intervention
Cocaine-Related Disorders
Opioid-Related Disorders
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Serotonin Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Estimated Enrollment: 220
Study Start Date: April 2001
Study Completion Date: March 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142779

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric C. Strain, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00142779     History of Changes
Other Study ID Numbers: NIDA-10754-2, R01-10754-2, DPMC
Study First Received: September 1, 2005
Last Updated: May 15, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Fluoxetine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014