ClinicalTrials.gov
ClinicalTrials.gov Menu

Vilazodone Treatment for Marijuana Dependence

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: NCT01574183
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : January 14, 2016
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Marijuana Dependence
Interventions Drug: Vilazodone
Drug: Placebo
Enrollment 76

Recruitment Details Participants recruited between August, 2012 and August, 2014 primarily through media and internet advertisements.
Pre-assignment Details  
Arm/Group Title Vilazodone Placebo
Hide Arm/Group Description

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily

Period Title: Overall Study
Started 41 35
Completed 14 17
Not Completed 27 18
Arm/Group Title Vilazodone Placebo Total
Hide Arm/Group Description

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily

Total of all reporting groups
Overall Number of Baseline Participants 41 35 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 35 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
 100.0%
35
 100.0%
76
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 35 participants 76 participants
Female
11
  26.8%
5
  14.3%
16
  21.1%
Male
30
  73.2%
30
  85.7%
60
  78.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 35 participants 76 participants
41 35 76
1.Primary Outcome
Title Percent Marijuana-negative Urine Drug Screens (UDS)
Hide Description Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone Placebo
Hide Arm/Group Description:

Flexible dose up to 40 mg capsule daily

Vilazodone: up to 40 mg capsule daily

Flexible dose up to 40 mg capsule daily

Placebo: up to 40 mg capsule daily

Overall Number of Participants Analyzed 41 35
Overall Number of Units Analyzed
Type of Units Analyzed: Urine samples
328 280
Measure Type: Number
Unit of Measure: percentage of UDS
5.5 3.6
2.Secondary Outcome
Title Weekly Cannabis Use Sessions
Hide Description Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone Placebo
Hide Arm/Group Description:

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily

Overall Number of Participants Analyzed 41 35
Mean (95% Confidence Interval)
Unit of Measure: weekly cannabis sessions
10
(8.1 to 11.8)
9.9
(8.2 to 11.7)
3.Secondary Outcome
Title Marijuana Craving and Withdrawal
Hide Description The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone Placebo
Hide Arm/Group Description:

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily

Overall Number of Participants Analyzed 41 35
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.9
(7.5 to 10.3)
11.3
(9.9 to 12.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vilazodone Placebo
Hide Arm/Group Description Flexible dose Vilazodone: up to 40 mg capsule daily Flexible dose Placebo: up to 40 mg capsule daily
All-Cause Mortality
Vilazodone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vilazodone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vilazodone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/41 (60.98%)      28/35 (80.00%)    
Gastrointestinal disorders     
Diarrhea *  5/41 (12.20%)  10 3/35 (8.57%)  3
Nausea *  13/41 (31.71%)  17 5/35 (14.29%)  8
Other GI *  3/41 (7.32%)  3 1/35 (2.86%)  1
Vomiting *  5/41 (12.20%)  8 0/35 (0.00%)  0
General disorders     
Allergies *  1/41 (2.44%)  1 4/35 (11.43%)  5
Other *  10/41 (24.39%)  17 10/35 (28.57%)  13
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  5/41 (12.20%)  7 6/35 (17.14%)  6
Nervous system disorders     
Dizzy/lightheaded *  4/41 (9.76%)  5 2/35 (5.71%)  2
Dream disturbance *  3/41 (7.32%)  3 1/35 (2.86%)  1
Headache *  8/41 (19.51%)  12 4/35 (11.43%)  10
Insomnia *  4/41 (9.76%)  5 5/35 (14.29%)  5
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection *  1/41 (2.44%)  1 7/35 (20.00%)  7
Congestion *  4/41 (9.76%)  4 9/35 (25.71%)  9
*
Indicates events were collected by non-systematic assessment
Limitations included small sample size, significant attrition, and difficulty with UCT (urine cannabinoid test) interpretation due to long excretion half-life of cannabis in urine.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aimee McRae-Clark, PharmD
Organization: MUSC
Phone: 843-792-5216
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01574183     History of Changes
Other Study ID Numbers: 16488
R21DA034089 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2012
First Posted: April 10, 2012
Results First Submitted: September 21, 2015
Results First Posted: January 14, 2016
Last Update Posted: August 10, 2016