Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Meets DSM-IV diagnosis criteria for current cocaine dependence

• Used cocaine at least one day in the month prior to study entry

• Meets DSM-IV criteria for major depression or dysthymia, with depression either primary (predates earliest life-time substance abuse), depression persistent during 6 months of cocaine abstinence in the past, or depression for at least 3 months prior to study entry

• If female, willing to use contraception throughout the study

Exclusion Criteria:

• Meets DSM-IV diagnosis criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse

• Chronic organic mental disorder

• Significant risk of suicide, based on current mental state or history

• Untreated seizure disorder or history of substance-related seizures

• Unstable physical disorders that may make study participation dangerous, including hypertension, hepatitis (mildly elevated transaminase levels that are less than 4 times the upper limit or normal levels are acceptable), and diabetes

• Coronary vascular disease, as indicated by medical history, suspected by abnormal ECG, or history of heart symptoms

• Irregular heartbeat as indicated by QRS duration greater than 0.11

• Current use of other prescribed psychotropic medications

• Currently meets DSM-IV diagnosis criteria for dependence on any drugs other than nicotine, marijuana, or alcohol

• History of allergic or adverse reaction to desipramine or venlafaxine

• Prior history of failing to respond to venlafaxine

• History of alcohol withdrawal syndrome in the year prior to study entry

• Current evidence of alcohol withdrawal, such as pulse rate greater than 115 beats per minute, blood pressure greater than 140/90 mm Hg, or visible tremors

• Pregnant or breastfeeding