Trial Outcomes & Findings for The Role of Sleep in the Treatment of Cannabis Use Disorders (NCT NCT01685073)

NCT ID: NCT01685073

Last Updated: 2019-05-22

Results Overview

Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 127 participants
• Primary outcome timeframe: Week 1 of treatment
• Results posted on: 2019-05-22

Participant Flow

Participant milestones

Measure	Zolpidem Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Overall Study STARTED	62	65
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	30	32

Reasons for withdrawal

Measure	Zolpidem Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Overall Study Lost to Follow-up	6	8
Overall Study Withdrawal by Subject	24	24

Baseline Characteristics

The Role of Sleep in the Treatment of Cannabis Use Disorders

Baseline characteristics by cohort

Measure	Zolpidem n=62 Participants Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo n=65 Participants Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Total n=127 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 9 • n=5 Participants	32 years STANDARD_DEVIATION 9 • n=7 Participants	31 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	42 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	63 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Tobacco Smoking Status	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1 of treatment

Population: Sleep data was not obtained for 12 people in the zolpidem group and 14 people in the placebo group at Week 1, and could not be included in this analysis. These individuals dropped out of the study or were lost to follow-up by the time of data collection.

Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.

Outcome measures

Measure	Zolpidem n=50 Participants Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo n=51 Participants Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed	78 percentage of time asleep while in bed Standard Deviation 16	74 percentage of time asleep while in bed Standard Deviation 19

PRIMARY outcome

Timeframe: Week 12

Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.

Outcome measures

Measure	Zolpidem n=62 Participants Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo n=65 Participants Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing Negative urine test	17 Participants	10 Participants
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing Positive urine test	45 Participants	55 Participants

Adverse Events

Zolpidem

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zolpidem n=62 participants at risk Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo n=65 participants at risk Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Vascular disorders Stroke, cerebrovascular accident	1.6% 1/62 • Number of events 1 • 12 weeks	0.00% 0/65 • 12 weeks
Infections and infestations Urinary tract infection	1.6% 1/62 • Number of events 1 • 12 weeks	0.00% 0/65 • 12 weeks

Other adverse events

Measure	Zolpidem n=62 participants at risk Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Zolpidem extended-release: nightly administration of zolpidem extended-release MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants	Placebo n=65 participants at risk Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
General disorders toothache	8.1% 5/62 • Number of events 5 • 12 weeks	4.6% 3/65 • Number of events 3 • 12 weeks
General disorders Headache	6.5% 4/62 • Number of events 4 • 12 weeks	7.7% 5/65 • Number of events 5 • 12 weeks
General disorders Cold symptoms	9.7% 6/62 • Number of events 6 • 12 weeks	13.8% 9/65 • Number of events 9 • 12 weeks
Gastrointestinal disorders nausea	11.3% 7/62 • Number of events 7 • 12 weeks	10.8% 7/65 • Number of events 7 • 12 weeks
Gastrointestinal disorders emesis	9.7% 6/62 • Number of events 6 • 12 weeks	9.2% 6/65 • Number of events 6 • 12 weeks
General disorders Sleep Difficulties	3.2% 2/62 • Number of events 2 • 12 weeks	7.7% 5/65 • Number of events 5 • 12 weeks

Additional Information

Ryan Vandrey, PhD

Johns Hopkins University

Phone: 410-550-4036

Email: rvandrey@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place