NCT01574183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

April 5, 2012

Results QC Date

September 21, 2015

Last Update Submit

July 8, 2016

Conditions

Marijuana Dependence

Keywords

MarijuanaVilazodoneContingency managementMotivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Weekly Cannabis Use Sessions

    8 weeks

  • Marijuana Craving and Withdrawal

    8 weeks

Study Arms (2)

Vilazodone

EXPERIMENTAL

Flexible dose up to 40 mg capsule daily

Drug: Vilazodone

Placebo

PLACEBO COMPARATOR

Flexible dose up to 40 mg capsule daily

Drug: Placebo

Interventions

VilazodoneDRUG

up to 40 mg capsule daily

Also known as: Viibryd
Vilazodone
PlaceboDRUG

up to 40 mg capsule daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndoles

Limitations and Caveats

Limitations included small sample size, significant attrition, and difficulty with UCT (urine cannabinoid test) interpretation due to long excretion half-life of cannabis in urine.

Results Point of Contact

Title
Aimee McRae-Clark, PharmD
Organization
MUSC
mcraeal@musc.edu
843-792-5216

Study Officials

  • Aimee L McRae-Clark, PharmD, BCPP

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 10, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

August 10, 2016

Results First Posted

January 14, 2016

Record last verified: 2016-07

Locations

US(1)