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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01574183
Other study ID # 16488
Secondary ID R21DA034089
Status Active, not recruiting
Phase Phase 2
First received April 5, 2012
Last updated December 10, 2015
Start date August 2012
Est. completion date March 2016

Study information

Verified date December 2015
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this study is to determine if the medication vilazodone is effective in helping frequent marijuana smokers cut down or stop using marijuana. Vilazodone is FDA approved for the treatment of depression- in this study, vilazodone's effect on marijuana dependence is being investigated.

Participation in the study takes 10 visits over a period of approximately two to three months. The first visit is a screening visit to determine if participants are eligible to participate. After the initial assessment visit, the weekly visits take about 30 minutes, with the exception of three therapy sessions which take approximately 60-90 minutes. The three therapy sessions will focus on participant's marijuana use and reasons they may have for stopping or cutting down on use. After completing an initial therapy session, participants will be randomly selected to receive the study medication, either vilazodone or placebo (a capsule that does not contain any active medication). Participants will have weekly study visits with a clinician. At each study visit, they will be asked to fill out forms and answer specific questions concerning their substance use, anxiety symptoms, and feelings in general. They will be providing urine samples to check for illegal drugs of abuse including marijuana and other drugs. They will also have blood samples drawn during to determine if you are taking the medication as directed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 76
Est. completion date March 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vilazodone
up to 40 mg capsule daily
Placebo
up to 40 mg capsule daily

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Marijuana-negative Urine Drug Screens (UDS) Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group. 8 weeks No
Secondary Weekly Cannabis Use Sessions Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption. 8 weeks No
Secondary Marijuana Craving and Withdrawal 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. 8 weeks No
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