Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals
Preliminary research has shown that venlafaxine, a medication currently used for treating depression, may also discourage cocaine use in depressed individuals. This study will evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression in individuals addicted to cocaine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Venlafaxine Treatment for Depressed Cocaine Abusers|
- Cocaine use [ Time Frame: baseline compared to 12 weeks of study or length of participation ] [ Designated as safety issue: No ]Proportion of patients achieving 3 weeks of cocaine abstinence based on self report and urine toxicology
- Hamilton Depression Rating Scale [ Time Frame: baseline compared to week 12 or last week of study participation ] [ Designated as safety issue: No ]Proportion of patients achieving a 50% reduction in HAM-D score at week 12 compared to baseline
|Study Start Date:||October 1999|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Other Name: Placebo
Venlafaxine 300mg daily
Other Name: Venlafaxine
Individuals addicted to cocaine often experience feelings of restlessness, irritability, and anxiety. They also often report feeling depressed when not using cocaine, and they tend to resume cocaine use to alleviate symptoms of depression. Venlafaxine is a medication that is currently used to treat depression and anxiety disorders. Preliminary research has shown that venlafaxine reduces depression, improves mood, and simultaneously reduces cocaine use in cocaine addicts. Further research is needed to confirm the benefits of venlafaxine for cocaine addicts. The purpose of this study is to evaluate the effectiveness of venlafaxine in reducing cocaine use, cocaine craving, and depression in individuals who are addicted to cocaine and diagnosed with depression.
This study will begin with a 1-week lead-in phase, during which all participants will receive placebo medication. Participants whose depression levels decrease will not continue in the treatment phase of the study, but will be eligible for cocaine relapse therapy and medication if deemed necessary by the treating psychiatrist. Participants who remain depressed following the lead-in phase will be randomly assigned to receive either venlafaxine or placebo for 12 weeks. Participants assigned to venlafaxine will initially receive a daily dose of 37.5 mg. After 4 days, the dose will be increased to 75 mg; each week thereafter, the dose will be increased by another 75 mg, up to a maximum of 300 mg per day, dependent on side effects and positive responses. Study visits will take place twice a week. At each visit, medication side effects and depression levels will be assessed, cocaine levels will be monitored with urine tests, and self-reports will be completed. Blood will be drawn once per month for laboratory tests. Participants will also attend a therapy session once a week, and they will meet with a psychiatrist every other week for assessments. Participants who show a decrease in depression during the 12 weeks of treatment will continue for an additional 12 weeks to further monitor cocaine use and depression levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249483
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Herbert Kleber, MD||New York State Psychiatric Institute|