Trial · NCT01574183
Vilazodone Treatment for Marijuana Dependence
NCT01574183, Phase 2, Completed, Medical University of South Carolina; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vilazodone Treatment for Marijuana Dependence. Trials, record NCT01574183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01574183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vilazodone Treatment for Marijuana Dependence
- NCT number
- NCT01574183
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Marijuana Dependence
- Interventions
- Vilazodone, Placebo
- First posted
- 2012-04-10
- Last updated
- 2016-08-10
- Results first posted
- 2016-01-14
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Marijuana-negative Urine Drug Screens (UDS) | 8 weeks | Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group. |
| Secondary | Weekly Cannabis Use Sessions | 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. |
| Secondary | Marijuana Craving and Withdrawal | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Marijuana-negative Urine Drug Screens (UDS) | 8 weeks | percentage of UDS | NUMBER | |
| SECONDARY | Weekly Cannabis Use Sessions | 8 weeks | weekly cannabis sessions | MEAN | |
| SECONDARY | Marijuana Craving and Withdrawal | 8 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Marijuana-negative Urine Drug Screens (UDS) | Vilazodone | 5.5 | percentage of UDS | ||
| Percent Marijuana-negative Urine Drug Screens (UDS) | Placebo | 3.6 | percentage of UDS | ||
| Weekly Cannabis Use Sessions | Vilazodone | 10 | 95% Confidence Interval 8.1 to 11.8 | weekly cannabis sessions | |
| Weekly Cannabis Use Sessions | Placebo | 9.9 | 95% Confidence Interval 8.2 to 11.7 | weekly cannabis sessions | |
| Marijuana Craving and Withdrawal | Vilazodone | 8.9 | 95% Confidence Interval 7.5 to 10.3 | units on a scale | |
| Marijuana Craving and Withdrawal | Placebo | 11.3 | 95% Confidence Interval 9.9 to 12.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vilazodone | 41 | |
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | COMPLETED | Vilazodone | 14 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Vilazodone | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergies | General disorders | Vilazodone | 1 | 41 | 1 |
| other | Allergies | General disorders | Placebo | 4 | 35 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Vilazodone | 5 | 41 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 35 | 3 |
| other | Dizzy/lightheaded | Nervous system disorders | Vilazodone | 4 | 41 | 5 |
| other | Dizzy/lightheaded | Nervous system disorders | Placebo | 2 | 35 | 2 |
| other | Dream disturbance | Nervous system disorders | Vilazodone | 3 | 41 | 3 |
| other | Dream disturbance | Nervous system disorders | Placebo | 1 | 35 | 1 |
| other | Headache | Nervous system disorders | Vilazodone | 8 | 41 | 12 |
| other | Headache | Nervous system disorders | Placebo | 4 | 35 | 10 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilazodone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vilazodone | 25 | 41 |
| Total, other adverse events | Placebo | 28 | 35 |
| Total, serious adverse events | Vilazodone | 0 | 41 |
| Total, serious adverse events | Placebo | 0 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DA034089 | Vilazodone treatment for marijuana dependence | MCRAE-CLARK, AIMEE L | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE ON DRUG ABUSE | 2012 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vilazodone vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01574183
GET https://conductscience.org/api/trials/v1/NCT01574183/events?page=2