Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts
Condition: Cocaine-Related Disorders; Opioid-Related Disorders
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine Addiction; Cocaine Dependence; Opiate Addiction; Opiate Dependence