Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1 (VEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131456
Recruitment Status : Completed
First Posted : August 18, 2005
Results First Posted : June 4, 2013
Last Update Posted : May 15, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

August 16, 2005
August 18, 2005
April 18, 2013
June 4, 2013
May 15, 2018
March 2004
December 2010   (Final data collection date for primary outcome measure)
Two Consecutive Weeks of Marijuana Abstinence [ Time Frame: measured daily by self report for 12 weeks of the trial or length of study participation ]
The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.
Withdrawl symptoms, biweekly, Weeks 1 through 12
Complete list of historical versions of study NCT00131456 on Archive Site
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Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Marijuana Abuse
  • Drug: Venlafaxine
    Other Name: Effexor
  • Drug: Placebo
  • Active Comparator: Venlafaxine
    Intervention: Drug: Venlafaxine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01DA015451 ( U.S. NIH Grant/Contract )
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Frances R Levin, National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, M.D. New York State Psychiatric Institute
New York State Psychiatric Institute
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP