Vilazodone Treatment for Marijuana Dependence
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ClinicalTrials.gov Identifier: NCT01574183 |
Recruitment Status
:
Completed
First Posted
: April 10, 2012
Results First Posted
: January 14, 2016
Last Update Posted
: August 10, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Marijuana Dependence | Drug: Vilazodone Drug: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Vilazodone Treatment for Marijuana Dependence |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Vilazodone
Flexible dose up to 40 mg capsule daily
|
Drug: Vilazodone
up to 40 mg capsule daily
Other Name: Viibryd
|
Placebo Comparator: Placebo
Flexible dose up to 40 mg capsule daily
|
Drug: Placebo
up to 40 mg capsule daily
|
- Percent Marijuana-negative Urine Drug Screens (UDS) [ Time Frame: 8 weeks ]Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.
- Weekly Cannabis Use Sessions [ Time Frame: 8 weeks ]Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.
- Marijuana Craving and Withdrawal [ Time Frame: 8 weeks ]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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574183
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Aimee L McRae-Clark, PharmD, BCPP | Medical University of South Carolina |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | April 10, 2012 Key Record Dates |
Results First Posted: | January 14, 2016 |
Last Update Posted: | August 10, 2016 |
Last Verified: | July 2016 |
Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
Marijuana Vilazodone Contingency management Motivational enhancement therapy |
Additional relevant MeSH terms:
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Vilazodone Hydrochloride Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists |