Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts

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.

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