Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression, Marijuana Abuse

In brief

The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.

Key facts

Study ID

NCT00131456

Run by

New York State Psychiatric Institute

People needed

123

Starts

2004-03-01

Expected to finish

2010-12-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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