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
Results First Received: April 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Marijuana Abuse
Interventions: Drug: Venlafaxine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from January 2004 through September 2010. Treatment seekers for problems related to marijuana use were recruited by local advertising or clinical referrals. Participants were treated at Columbia University/New York State Psychiatric Institute or at Columbia University/North Shore-LIJ Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial included a one-week placebo lead-in. Placebo responders during the placebo lead in (N = 7), defined as a Clinical Global Impression rating of 1 or 2 and a reduction in the Hamilton Depression score > 75% or total score ≤ 7, were not randomized. Additionally, 13 participants were lost to follow-up so a total of 103 were randomized.

Reporting Groups
  Description
Placebo Matched Placebo
Venlafaxine Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 ("very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.

Participant Flow:   Overall Study
    Placebo     Venlafaxine  
STARTED     52     51  
COMPLETED     33     31  
NOT COMPLETED     19     20  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matched Placebo
Venlafaxine Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
Total Total of all reporting groups

Baseline Measures
    Placebo     Venlafaxine     Total  
Number of Participants  
[units: participants]
  52     51     103  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     52     51     103  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.9  ± 9.3     34.2  ± 10.8     35.1  ± 10.1  
Gender  
[units: participants]
     
Female     11     16     27  
Male     41     35     76  
Region of Enrollment  
[units: participants]
     
United States     52     51     103  



  Outcome Measures

1.  Primary:   Two Consecutive Weeks of Marijuana Abstinence   [ Time Frame: measured daily by self report for 12 weeks of the trial or length of study participation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was an outpatient study and excluded patients with very severe depression. Thus we cannot generalize the findings to individuals with more severe depressive symptoms. The study length was relatively brief.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Frances R. Levin
Organization: Columbia University
phone: 212-543-5896
e-mail: frl2@columbia.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00131456     History of Changes
Other Study ID Numbers: #4695, R01DA015451
Study First Received: August 16, 2005
Results First Received: April 18, 2013
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government