Status:
COMPLETED
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Depression
Marijuana Abuse
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Detailed Description
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effe...
Eligibility Criteria
Inclusion
- Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
- Currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the Hamilton Depression Inventory
- Clinically depressed for at least 3 months during a period of active marijuana use
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant, the study medication will be discontinued.
Exclusion
- Meets criteria for past manic or psychotic disorder, unless substance-related
- History of a seizure disorder
- Individuals with chronic organic mental syndrome
- Any significant risk for suicide based on current assessment and history of attempts
- History of allergic reaction to either Venlafaxine or Ven-XR
- Unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (SBP\>150, DBP \>90, or a sitting quietly HR\>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (\<2x upper limit of normal are acceptable) or unstable diabetes
- History of failure to respond to a previous adequate trial of Venlafaxine of at least 300 mg. for at least a 6-week period
- Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
- Currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
- Pregnant or breast-feeding
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00131456
Start Date
March 1 2004
End Date
December 1 2010
Last Update
April 24 2019
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032