Vilazodone Treatment for Marijuana Dependence

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Marijuana Dependence	Drug: Vilazodone; Drug: Placebo	Phase 2

Detailed 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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Aimee L McRae-Clark, PharmD, BCPP	Medical University of South Carolina

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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