Phase 2
N=76
Vilazodone Treatment for Marijuana Dependence
Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01574183 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Percent Marijuana-negative Urine Drug Screens (UDS) — 5.5; 3.6 percentage of UDS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vilazodone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Marijuana-negative Urine Drug Screens (UDS) |
5.5; 3.6 | — |
| SECONDARY Weekly Cannabis Use Sessions |
10; 9.9 | — |
| SECONDARY Marijuana Craving and Withdrawal |
8.9; 11.3 | — |
Summary
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01574183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.