Status:
COMPLETED
Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-Related Disorders
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 effectivene...
Detailed Description
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00249483
Start Date
October 1 1999
End Date
February 1 2005
Last Update
July 11 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032