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

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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)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Marijuana Abuse
Interventions Drug: Venlafaxine
Drug: Placebo
Enrollment 123
Recruitment Details 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 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.
Arm/Group Title Placebo Venlafaxine
Hide Arm/Group Description Matched Placebo 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.
Period Title: Overall Study
Started 52 51
Completed 33 31
Not Completed 19 20
Arm/Group Title Placebo Venlafaxine Total
Hide Arm/Group Description Matched Placebo 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 of all reporting groups
Overall Number of Baseline Participants 52 51 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
51
 100.0%
103
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 51 participants 103 participants
35.9  (9.3) 34.2  (10.8) 35.1  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
Female
11
  21.2%
16
  31.4%
27
  26.2%
Male
41
  78.8%
35
  68.6%
76
  73.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 51 participants 103 participants
52 51 103
1.Primary Outcome
Title Two Consecutive Weeks of Marijuana Abstinence
Hide Description 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.
Time Frame measured daily by self report for 12 weeks of the trial or length of study participation
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were conducted based on the intent-to-treat principle.
Arm/Group Title Placebo Venlafaxine
Hide Arm/Group Description:
Matched Placebo
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.
Overall Number of Participants Analyzed 52 51
Measure Type: Number
Unit of Measure: participants
19 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Venlafaxine
Comments Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Venlafaxine
Hide Arm/Group Description Matched Placebo 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.
All-Cause Mortality
Placebo Venlafaxine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Venlafaxine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/51 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Venlafaxine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/52 (46.15%)      33/51 (64.71%)    
Gastrointestinal disorders     
diarrhea   3/52 (5.77%)  3 4/51 (7.84%)  4
GI Upset   2/52 (3.85%)  2 6/51 (11.76%)  6
nausea   4/52 (7.69%)  4 6/51 (11.76%)  6
General disorders     
dizziness   2/52 (3.85%)  2 8/51 (15.69%)  8
fatigue   1/52 (1.92%)  1 6/51 (11.76%)  6
headache   4/52 (7.69%)  4 2/51 (3.92%)  2
insomnia   4/52 (7.69%)  4 7/51 (13.73%)  7
loss of libido   0/52 (0.00%)  0 6/51 (11.76%)  6
muscle aches   4/52 (7.69%)  4 2/51 (3.92%)  2
syncopy or light headedness   4/52 (7.69%)  4 2/51 (3.92%)  2
Psychiatric disorders     
anxiety   1/52 (1.92%)  1 6/51 (11.76%)  6
Indicates events were collected by systematic assessment
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.
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
Responsible Party: Frances R Levin, 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 Submitted: August 16, 2005
First Posted: August 18, 2005
Results First Submitted: April 18, 2013
Results First Posted: June 4, 2013
Last Update Posted: April 24, 2019