Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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