Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

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.

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: Venlafaxine
  • Venlafaxine
• Placebo Comparator: Placebo
  • Placebo

Primary Measures

• Two weeks of Marijuana abstinence
  • Time Frame: measured daily by self report for 12 weeks of the trial or length of study participation
    Safety Issue?: No
• Depressive symptoms based on Hamilton Depression Score
  • Time Frame: measured once per week for 12 weeks or length of study participation
    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 Investigator: New York State Psychiatric Institute Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 08, 2012

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

Study ID Number: #4695

ClinicalTrials.gov Identifier: NCT00131456

Health Authority: United States: Food and Drug Administration