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Vilazodone Treatment for Marijuana Dependence

This study is currently recruiting participants.
Verified April 2013 by Medical University of South Carolina
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01574183
First received: April 5, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of vilazodone for reducing marijuana use in marijuana-dependent adults. A contingency management intervention (CM)and motivational enhancement therapy (MET)will be incorporated to encourage study engagement and retention, and genomic DNA will be extracted to characterize subjects according to polymorphisms of genes potentially relevant to the activity of vilazodone. It is hypothesized that vilazodone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.


Condition Intervention Phase
Marijuana Dependence
 Drug: Vilazodone
Drug: Placebo
 Phase 2

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
Official Title: Vilazodone Treatment for Marijuana Dependence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Percent marijuana-positive urine drug screens [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary outcome for this study is the proportion of urine drug screens positive for marijuana.


Secondary Outcome Measures:
  • Time to first negative urine drug screen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary efficacy endpoint is time to first negative (passed) urine screen.

  • Percent of marijuana-positive self-reported days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary efficacy endpoint is percentage of marijuana-positive self-reported days

  • Study retention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary efficacy endpoint is retention in the study.

  • Marijuana craving and withdrawal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary endpoint of marijuana craving and withdrawal


Estimated Enrollment: 76
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vilazodone
40 mg capsule daily
 Drug: Vilazodone
40 mg capsule daily
Placebo Comparator: Placebo
40 mg capsule daily
 Drug: Placebo
40 mg capsule daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must meet DSM-IV criteria for marijuana dependence
  • Must be between the ages of 18 and 65 years old
  • If female and of childbearing potential, must agree to use acceptable method of birth control for duration of the trial.
  • Cannabis-positive urine drug screen at screening
  • Must consent to random assignment
  • Must be able to read and provide informed consent

Exclusion Criteria:

  • Women who are pregnant, nursing, or plan to become pregnant during course of study
  • Must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder
  • Must not meet criteria for current major depressive or generalized anxiety disorder
  • Must not pose a current suicidal or homicidal risk
  • Must not have evidence or history of serious medical disease
  • Must not require concomitant therapy with psychotropic medication or CYP3A4 inhibitors
  • Must not be currently dependent on other substances, with the exception of nicotine;
  • Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574183

Contacts
Contact: Amanda Wagner, MA, LPC 843-792-0484 wagne@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Wagner, MA, LPC     843-792-0484     wagne@musc.edu    
Principal Investigator: Aimee L McRae-Clark, PharmD, BCPP            
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Aimee L McRae-Clark, PharmD, BCPP MUSC
  More Information

No publications provided

Responsible Party: Aimee McRae-Clark, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01574183     History of Changes
Other Study ID Numbers: 16488, R21DA034089
Study First Received: April 5, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Marijuana
Vilazodone
Contingency management
Motivational enhancement therapy

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013