The Role of Sleep in the Treatment of Cannabis Use Disorders

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01685073
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 127
• Location: 1
• Arms: 2
• Duration (Months): 69.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.

Condition or Disease	Intervention/Treatment	Phase
Drug Addiction	Drug: Zolpidem extended-release; Behavioral: MET/CBT	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Role of Sleep in the Treatment of Cannabis Use Disorders
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolpidem Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder	Drug: Zolpidem extended-release; nightly administration of zolpidem extended-release; Other Names: Ambien CR ; Behavioral: 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 Comparator: Placebo Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed [Week 1 of treatment]

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

2. Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing [Week 12]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 18-55 years.

2. Recent problematic use of cannabis

3. Cannabis use impacts sleep

Exclusion Criteria:

1. Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder

2. Moderate sleep apnea or periodic limb movement disorder

3. Pregnant, breast feeding, or planning to become pregnant within the next 3 months

4. Current condition associated with severe cognitive/social impairment

5. Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem

6. Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment

7. Current use of hypnotic medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Ryan Vandrey, PhD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 15, 2015

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01685073
• Other Study ID Numbers: NA_00068969; U01DA031784
• First Posted: Sep 13, 2012
• Last Update Posted: May 22, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Johns Hopkins University: marijuana; cannabis; treatment; insomnia; relapse
• Additional relevant MeSH terms: Marijuana Abuse; Substance-Related Disorders; Zolpidem

Study Results

Participant Flow

Arm/Group Title	Zolpidem	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	62	65
COMPLETED	32	33
NOT COMPLETED	30	32

Baseline Characteristics

Arm/Group Title	Zolpidem	Placebo	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	62	65	127
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31 (9)	32 (9)	31 (9)
Sex: Female, Male (Count of Participants)
Female	25 40.3%	23 35.4%	48 37.8%
Male	37 59.7%	42 64.6%	79 62.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 8.1%	2 3.1%	7 5.5%
Not Hispanic or Latino	57 91.9%	63 96.9%	120 94.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Tobacco Smoking Status (Count of Participants)
Count of Participants [Participants]	36 58.1%	36 55.4%	72 56.7%

Outcome Measures

1. Primary Outcome

Title	Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
Description	Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Time Frame	Week 1 of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Zolpidem	Placebo
Arm/Group Description	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	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
Measure Participants	50	51
Mean (Standard Deviation) [percentage of time asleep while in bed]	78 (16)	74 (19)

2. Primary Outcome

Title	Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
Description	Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zolpidem	Placebo
Arm/Group Description	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	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
Measure Participants	62	65
Negative urine test	17 27.4%	10 15.4%
Positive urine test	45 72.6%	55 84.6%

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Zolpidem		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Zolpidem		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/65 (0%)
Serious Adverse Events
	Zolpidem		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/62 (3.2%)		0/65 (0%)
Infections and infestations
Urinary tract infection	1/62 (1.6%)	1	0/65 (0%)	1
Vascular disorders
Stroke, cerebrovascular accident	1/62 (1.6%)	1	0/65 (0%)	0
Other (Not Including Serious) Adverse Events
	Zolpidem		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/62 (48.4%)		35/65 (53.8%)
Gastrointestinal disorders
nausea	7/62 (11.3%)	7	7/65 (10.8%)	7
emesis	6/62 (9.7%)	6	6/65 (9.2%)	6
General disorders
toothache	5/62 (8.1%)	5	3/65 (4.6%)	3
Headache	4/62 (6.5%)	4	5/65 (7.7%)	5
Cold symptoms	6/62 (9.7%)	6	9/65 (13.8%)	9
Sleep Difficulties	2/62 (3.2%)	2	5/65 (7.7%)	5

Limitations/Caveats

There was a significant number of participant drop-outs in both study arms

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.