Official Title: “Marijuana Addiction and Depression: Venlafaxine Treatment”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Venlafaxine
  • 375mg/day
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Venlafaxine
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Withdrawl symptoms, biweekly, Weeks 1 through 12
  • Time Frame: biweekly
    Safety Issue?: No

Inclusion Criteria:

• Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
• Currently meets criteria for depression
• Clinically depressed for at least 3 months during a period of active marijuana use

Exclusion Criteria:

• Meets criteria for past manic or psychotic disorder, unless substance-related
• History of seizures
• History of allergic reaction to either Venlafaxine or Ven-XR
• Unstable medical conditions
• Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
• Pregnant or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Frances R Levin, M.D. Principal Investigator New York State Psychiatric Institute  

Overall Contact: Substance Abuse Treatment and Research Service (212) 923-3031 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00131456

Study ID Number: NIDA-15451-1

ClinicalTrials.gov Identifier: NCT00131456

Health Authority: United States: Food and Drug Administration

Click here for the Substance Treatment and Research Service website