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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited between August, 2012 and August, 2014 primarily through media and internet advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vilazodone

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Placebo

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily


Participant Flow:   Overall Study
    Vilazodone   Placebo
STARTED   41   35 
COMPLETED   14   17 
NOT COMPLETED   27   18 



  Baseline Characteristics

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
Vilazodone

Flexible dose up to 40 mg capsule daily

Vilazodone: 40 mg capsule daily

Placebo

Flexible dose up to 40 mg capsule daily

Placebo: 40 mg capsule daily

Total Total of all reporting groups

Baseline Measures
   Vilazodone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   35   76 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   41   35   76 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   11   5   16 
Male   30   30   60 
Region of Enrollment 
[Units: Participants]
     
United States   41   35   76 


  Outcome Measures

1.  Primary:   Percent Marijuana-negative Urine Drug Screens (UDS)   [ Time Frame: 8 weeks ]

2.  Secondary:   Weekly Cannabis Use Sessions   [ Time Frame: 8 weeks ]

3.  Secondary:   Marijuana Craving and Withdrawal   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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.


  More Information

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
e-mail: mcraeal@musc.edu



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