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Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Marijuana Abuse

Intervention: Venlafaxine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Frances R Levin, M.D., Principal Investigator, Affiliation: New York State Psychiatric Institute


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

Clinical Details

Official title: Marijuana Addiction and Depression: Venlafaxine Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Two Consecutive Weeks of Marijuana Abstinence

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 effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction. During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Locations and Contacts

New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information

Starting date: March 2004
Last updated: March 30, 2015

Page last updated: August 23, 2015

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