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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.
 
ClinicalTrials.gov Identifier: NCT00131456
Recruitment Status : Completed
First Posted : August 18, 2005
Results First Posted : June 4, 2013
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE August 16, 2005
First Posted Date  ICMJE August 18, 2005
Results First Submitted Date  ICMJE April 18, 2013
Results First Posted Date  ICMJE June 4, 2013
Last Update Posted Date April 24, 2019
Study Start Date  ICMJE March 2004
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
Withdrawl symptoms, biweekly, Weeks 1 through 12
Change History Complete list of historical versions of study NCT00131456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Official Title  ICMJE Marijuana Addiction and Depression: Venlafaxine Treatment
Brief Summary The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Marijuana Abuse
Intervention  ICMJE
  • Drug: Venlafaxine
    375mg/day
    Other Name: Effexor
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Venlafaxine
    Venlafaxine
    Intervention: Drug: Venlafaxine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
123
Original Enrollment  ICMJE
 (submitted: August 16, 2005)
180
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131456
Other Study ID Numbers  ICMJE #4695
R01DA015451 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frances R Levin, National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Frances R Levin, M.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date April 2019

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