ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 15, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Depression Marijuana Abuse Drug: Venlafaxine Drug: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Marijuana Addiction and Depression: Venlafaxine Treatment
Study Start Date : March 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Venlafaxine
Venlafaxine
Drug: Venlafaxine
375mg/day
Other Name: Effexor

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131456


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Frances R Levin, M.D. New York State Psychiatric Institute

Additional Information:
Responsible Party: Frances R Levin, Director of Substance Use Disorder, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00131456     History of Changes
Other Study ID Numbers: #4695
R01DA015451 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2005    Key Record Dates
Results First Posted: June 4, 2013
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Frances R Levin, National Institute on Drug Abuse (NIDA):
cannabis dependence
depression
treatment
venlafaxine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Marijuana Abuse
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs