Free Venlafaxine Treatment for Marijuana Addiction and Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depression Marijuana Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Venlafaxine

Group Type ACTIVE_COMPARATOR

Venlafaxine

Intervention Type DRUG

375mg/day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Venlafaxine

375mg/day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Effexor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No