Trial Outcomes & Findings for Vilazodone Treatment for Marijuana Dependence (NCT NCT01574183)

NCT ID: NCT01574183

Last Updated: 2016-08-10

Results Overview

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-08-10

Participant Flow

Participants recruited between August, 2012 and August, 2014 primarily through media and internet advertisements.

Participant milestones

Participant milestones
Measure	Vilazodone Flexible dose up to 40 mg capsule daily Vilazodone: 40 mg capsule daily	Placebo Flexible dose up to 40 mg capsule daily Placebo: 40 mg capsule daily
Overall Study STARTED	41	35
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	27	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vilazodone Treatment for Marijuana Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vilazodone n=41 Participants Flexible dose up to 40 mg capsule daily Vilazodone: 40 mg capsule daily	Placebo n=35 Participants Flexible dose up to 40 mg capsule daily Placebo: 40 mg capsule daily	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	35 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Outcome measures

Outcome measures
Measure	Vilazodone n=328 Urine samples Flexible dose up to 40 mg capsule daily Vilazodone: up to 40 mg capsule daily	Placebo n=280 Urine samples Flexible dose up to 40 mg capsule daily Placebo: up to 40 mg capsule daily
Percent Marijuana-negative Urine Drug Screens (UDS)	5.5 percentage of UDS	3.6 percentage of UDS

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vilazodone n=41 Participants Flexible dose up to 40 mg capsule daily Vilazodone: up to 40 mg capsule daily	Placebo n=35 Participants Flexible dose up to 40 mg capsule daily Placebo: up to 40 mg capsule daily
Weekly Cannabis Use Sessions	10 weekly cannabis sessions Interval 8.1 to 11.8	9.9 weekly cannabis sessions Interval 8.2 to 11.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vilazodone n=41 Participants Flexible dose up to 40 mg capsule daily Vilazodone: up to 40 mg capsule daily	Placebo n=35 Participants Flexible dose up to 40 mg capsule daily Placebo: up to 40 mg capsule daily
Marijuana Craving and Withdrawal	8.9 units on a scale Interval 7.5 to 10.3	11.3 units on a scale Interval 9.9 to 12.7

Adverse Events

Vilazodone

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vilazodone n=41 participants at risk Flexible dose Vilazodone: up to 40 mg capsule daily	Placebo n=35 participants at risk Flexible dose Placebo: up to 40 mg capsule daily
General disorders Allergies	2.4% 1/41 • Number of events 1	11.4% 4/35 • Number of events 5
Gastrointestinal disorders Diarrhea	12.2% 5/41 • Number of events 10	8.6% 3/35 • Number of events 3
Nervous system disorders Dizzy/lightheaded	9.8% 4/41 • Number of events 5	5.7% 2/35 • Number of events 2
Nervous system disorders Dream disturbance	7.3% 3/41 • Number of events 3	2.9% 1/35 • Number of events 1
Nervous system disorders Headache	19.5% 8/41 • Number of events 12	11.4% 4/35 • Number of events 10
Musculoskeletal and connective tissue disorders Musculoskeletal	12.2% 5/41 • Number of events 7	17.1% 6/35 • Number of events 6
Gastrointestinal disorders Nausea	31.7% 13/41 • Number of events 17	14.3% 5/35 • Number of events 8
Gastrointestinal disorders Other GI	7.3% 3/41 • Number of events 3	2.9% 1/35 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	2.4% 1/41 • Number of events 1	20.0% 7/35 • Number of events 7
Gastrointestinal disorders Vomiting	12.2% 5/41 • Number of events 8	0.00% 0/35
Respiratory, thoracic and mediastinal disorders Congestion	9.8% 4/41 • Number of events 4	25.7% 9/35 • Number of events 9
Nervous system disorders Insomnia	9.8% 4/41 • Number of events 5	14.3% 5/35 • Number of events 5
General disorders Other	24.4% 10/41 • Number of events 17	28.6% 10/35 • Number of events 13

Additional Information

Aimee McRae-Clark, PharmD

MUSC

Phone: 843-792-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place