Trial Outcomes & Findings for Buspirone Treatment for Marijuana Dependence (NCT NCT00875836)

NCT ID: NCT00875836

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

PHASE4

Target enrollment

175 participants

Primary outcome timeframe

Participants provided a once-weekly urine sample for twelve weeks

Results posted on

2016-08-10

Participant Flow

Participants recruited between November 2009 and March 2014 primarily through media and internet advertisements.

Participant milestones

Participant milestones
Measure	Buspirone Buspirone: Flexible dose up to 60 mg/day	Placebo Placebo: Flexible dose up to 60mg/day
Overall Study STARTED	88	87
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	43	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buspirone Treatment for Marijuana Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buspirone n=88 Participants Buspirone: 30 mg capsules twice daily	Placebo n=87 Participants Placebo: 30 mg capsules twice daily	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=99 Participants	87 Participants n=107 Participants	175 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	21 Participants n=99 Participants	20 Participants n=107 Participants	41 Participants n=206 Participants
Sex: Female, Male Male	67 Participants n=99 Participants	67 Participants n=107 Participants	134 Participants n=206 Participants
Region of Enrollment United States	88 participants n=99 Participants	87 participants n=107 Participants	175 participants n=206 Participants

PRIMARY outcome

Timeframe: Participants provided a once-weekly urine sample for twelve weeks

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

Outcome measures

Outcome measures
Measure	Buspirone n=1056 UDS samples Buspirone: Flexible dose up to 60 mg/day	Placebo n=1044 UDS samples Placebo: Flexible dose up to 60mg/day
Percent Marijuana-negative Urine Drug Screens (UDS)	7.2 percentage of UDS	6.4 percentage of UDS

SECONDARY outcome

Timeframe: participants were followed for twelve weeks

Number of days subjects remained active in the study

Outcome measures

Outcome measures
Measure	Buspirone n=88 Participants Buspirone: Flexible dose up to 60 mg/day	Placebo n=87 Participants Placebo: Flexible dose up to 60mg/day
Retention in the Study	79 Day Interval 18.0 to 91.0	84 Day Interval 14.0 to 91.0

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- reported here is the mean composite score across the 8 week treatment course.

Outcome measures

Outcome measures
Measure	Buspirone n=88 Participants Buspirone: Flexible dose up to 60 mg/day	Placebo n=87 Participants Placebo: Flexible dose up to 60mg/day
Marijuana Craving	29.6 units on a scale Interval 27.0 to 32.2	28.4 units on a scale Interval 25.8 to 31.1

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Buspirone n=88 participants at risk Buspirone: Flexible dose up to 60 mg/day	Placebo n=87 participants at risk Placebo: Flexible dose up to 60mg/day
Psychiatric disorders Anxiety or Depression	4.5% 4/88 • Number of events 5	5.7% 5/87 • Number of events 5
Nervous system disorders Dizziness or lightheaded	40.9% 36/88 • Number of events 44	12.6% 11/87 • Number of events 17
Nervous system disorders Drowsiness	19.3% 17/88 • Number of events 19	17.2% 15/87 • Number of events 18
Gastrointestinal disorders Gastrointestinal	40.9% 36/88 • Number of events 61	26.4% 23/87 • Number of events 35
Nervous system disorders Headache	31.8% 28/88 • Number of events 55	31.0% 27/87 • Number of events 46
Nervous system disorders Insomnia	18.2% 16/88 • Number of events 17	17.2% 15/87 • Number of events 17
Musculoskeletal and connective tissue disorders Musculoskeletal	12.5% 11/88 • Number of events 19	27.6% 24/87 • Number of events 32
General disorders Sinus/allergies/flu	14.8% 13/88 • Number of events 19	13.8% 12/87 • Number of events 16
Respiratory, thoracic and mediastinal disorders Congestion	21.6% 19/88 • Number of events 26	20.7% 18/87 • Number of events 23
General disorders Other	48.9% 43/88 • Number of events 87	46.0% 40/87 • Number of events 83

Additional Information

Dr. Aimee McRae-Clark

MUSC

Phone: 843.792.5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place