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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00131456 |
Purpose
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Marijuana Abuse |
Drug: Venlafaxine Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Marijuana Addiction and Depression: Venlafaxine Treatment |
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Venlafaxine
|
Drug: Venlafaxine
375mg/day
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Substance Abuse Treatment and Research Service | (212) 923-3031 |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Daniel J Brooks, M.A. 212-740-3205 | |
| Principal Investigator: Frances R Levin, M.D. | |
| Principal Investigator: | Frances R Levin, M.D. | New York State Psychiatric Institute |
More Information
| Responsible Party: | Columbia University/NYSPI ( Frances R. Levin, M.D ) |
| Study ID Numbers: | NIDA-15451-1, R01-15451-1, DPMC |
| Study First Received: | August 16, 2005 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00131456 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
Behavior, Addictive Depression Mental Disorders Venlafaxine Substance-Related Disorders Mood Disorders |
Disorders of Environmental Origin Depressive Disorder Marijuana Abuse Serotonin Behavioral Symptoms |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |
