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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00131456
First received: August 16, 2005
Last updated: June 4, 2013
Last verified: June 2013

August 16, 2005
June 4, 2013
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Marijuana Abuse
  • Drug: Venlafaxine
    375mg/day
    Other Name: Effexor
  • Drug: Placebo
    Placebo
    Other Name: placebo
  • Active Comparator: Venlafaxine
    Venlafaxine
    Intervention: Drug: Venlafaxine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131456
#4695, R01DA015451
Yes
New York State Psychiatric Institute
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
June 2013

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