Clinical Trial: Venlafaxine Treatment for Marijuana Dependence and Depression - 1

This study is currently recruiting patients.
Verified by National Institute on Drug Abuse (NIDA) August 2005

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00131456

Purpose

Because depression and marijuana dependence can occur together, drugs aimed at treating individuals diagnosed with both conditions may be particularly effective. Venlafaxine-Extended-Release (Ven-XR), a once-a-day medication commonly used to treat depression, is a promising option. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with both depression and marijuana dependence.
Condition Intervention Phase
Depression
Marijuana Abuse
 Drug: Venlafaxine
Phase II

MedlinePlus related topics:  Depression;   Marijuana

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Marijuana Dependence and Depression: Venlafaxine Treatment

Further Study Details: 
Primary Outcomes: Withdrawl symptoms, biweekly, Weeks 1 through 12
Expected Total Enrollment:  180

Study start: March 2004

Given the comorbidity of depression and marijuana dependence, drugs aimed at treating individuals diagnosed with both conditions may be particularly effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana dependence.

This 12-week study will occur in two phases. Phase 1 will be a single-blind, placebo-controlled lead-in phase, lasting 1 week. Phase 2 will be a double-blind, placebo-controlled treatment phase, lasting 11 weeks. Phase 1 will indentify placebo responders, who are individuals affected by the placebo. Participants who respond to the placebo in terms of depression will not continue in the formal study or be included in the statistical analysis. However, they will be eligible for the entire course of cognitive behavioral treatment and medication if the treating psychiatrist feels it is clinically necessary. Participants who respond to the placebo in terms of marijuana dependence will continue in the study. This is justified because brief periods of abstinence or reduced use of marijuana do not indicate remission of substance abuse. During Phase 2, participants will be randomly assigned to receive either placebo or Ven-XR. Participants receiving Ven-XR will begin active psychopharmacological treatment at the start of Week 2 and will receive a stable dose of Ven-XR by Week 5. Study visits will occur twice each week. During study visits, participants will receive placebo or medication and will be asked to provide a supervised urine sample for drug screening. Blood tests will be collected each month to determine Ven-XR blood levels. In addition, women will take pregnancy tests each month. At each study visit, participants will be given $5 to defray transportation costs. Throughout the study, all participants will receive individualized psychotherapy sessions.

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for current marijuana dependence and reports marijuana as the primary drug of abuse
  • Currently meets DSM-IV criteria for major depression or dysthymic disorder and receives a total score of greater than 12 on the Hamilton Depression Inventory (HAM-D)
  • Diagnosed as clinically depressed for at least 3 months during a period of active marijuana use
  • Women of childbearing age will be included provided that they are not pregnant (tested at initial screening) and they agree to use an effective method of contraception throughout the study

Exclusion Criteria:

  • Meets DSM-IV criteria for past mania, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
  • History of seizures
  • History of allergic reaction to either Venlafaxine or Ven-XR
  • Current diagnosis of chronic organic mental syndrome
  • Currently at risk for suicide
  • Unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension (systolic blood pressure greater than 150, diastolic blood pressure greater than 90), a faster than normal heart rate (resting heart rate greater than 100 beats per minute), acute hepatitis, chronic elevated transaminase levels (greater than 2 times the upper limit of the normal level), or unstable diabetes
  • Liver enzyme function tests greater than 2 times the normal level
  • History or current symptoms of heart disease (including an abnormal ECG that suggests heart disease)
  • History of failure to respond to a previous trial of at least 300 mg of Venlafaxine for at least a 6-week period
  • Physiologically dependent on any other drugs (excluding nicotine) that would require medical detoxification
  • Currently taking psychotropic medication for any illness other than acute treatment of insomnia
  • Pregnancy or breastfeeding
  • Current dependence on amphetamines and/or cocaine will not be an exclusion but will prompt a warning about the possible negative effects of using such substance while taking Ven-XR

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131456

Laura Diaz, B.A.      (212)740-7307    diazlau@pi.cpmc.columbia.edu

New York
      New York State Psychiatric Institute, New York,  New York,  10032,  United States; Recruiting
Daniel J Brooks, M.A.  212-740-7289 

Study chairs or principal investigators

Frances R Levin, M.D.,  Principal Investigator,  New York State Psychiatric Institute   

More Information

Study ID Numbers:  NIDA-15451-1; R01-15451-1
Last Updated:  August 17, 2005
Record first received:  August 16, 2005
ClinicalTrials.gov Identifier:  NCT00131456
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23



Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us