Trial Outcomes & Findings for Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis (NCT NCT03964974)

NCT ID: NCT03964974

Last Updated: 2022-09-14

Results Overview

The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. The range of the ISI is 0 to 28, with 28 corresponding to maximum severity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

16 Weeks

Results posted on

2022-09-14

Participant Flow

Participant milestones

Participant milestones
Measure
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
Each CBTi-CB therapy session reviewed the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment addressed cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Sleep Hygiene Education (SHE)
The SHE condition was matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
Overall Study
STARTED
30
27
Overall Study
Assigned and Received Intervention
26
21
Overall Study
8 Week Follow Up
26
22
Overall Study
16 Week Follow Up
27
22
Overall Study
COMPLETED
27
22
Overall Study
NOT COMPLETED
3
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
Each CBTi-CB therapy session reviewed the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment addressed cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Sleep Hygiene Education (SHE)
The SHE condition was matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
Overall Study
Lost to Follow-up
3
2
Overall Study
Withdrawal by Subject
0
3

Baseline Characteristics

Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CBTi-CB
n=30 Participants
Cognitive Behavioral Therapy for Insomnia in Cannabis Users Cognitive Behavioral Therapy for Insomnia in Cannabis Users: Each CBTi-CB therapy session reviewed the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment addressed cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Sleep Hygiene Education
n=27 Participants
Sleep Hygiene Education The SHE condition was matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
Total
n=57 Participants
Total of all reporting groups
Age, Continuous
36.7 years
STANDARD_DEVIATION 12.0 • n=99 Participants
38.7 years
STANDARD_DEVIATION 13.7 • n=107 Participants
37.6 years
STANDARD_DEVIATION 12.8 • n=206 Participants
Sex/Gender, Customized
Female
23 Participants
n=99 Participants
20 Participants
n=107 Participants
43 Participants
n=206 Participants
Sex/Gender, Customized
Male
7 Participants
n=99 Participants
7 Participants
n=107 Participants
14 Participants
n=206 Participants
Sex/Gender, Customized
Non-Binary
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=99 Participants
25 Participants
n=107 Participants
55 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=99 Participants
2 Participants
n=107 Participants
6 Participants
n=206 Participants
Race (NIH/OMB)
White
24 Participants
n=99 Participants
23 Participants
n=107 Participants
47 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
30 Participants
n=99 Participants
27 Participants
n=107 Participants
57 Participants
n=206 Participants
Insomnia Severity Index (ISI)
17.4 units on a scale
STANDARD_DEVIATION 4.5 • n=99 Participants
16.2 units on a scale
STANDARD_DEVIATION 3.8 • n=107 Participants
16.8 units on a scale
STANDARD_DEVIATION 4.2 • n=206 Participants
Frequency of Cannabis Use
Participants Who Used 2 - 3 Times/Week
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Frequency of Cannabis Use
Participants Who Used 4 or More Times/Week
26 Participants
n=99 Participants
24 Participants
n=107 Participants
50 Participants
n=206 Participants
Cannabis Use Per Day
Less Than Daily Use
2 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
Cannabis Use Per Day
1 - 2 Times Per Day
10 Participants
n=99 Participants
12 Participants
n=107 Participants
22 Participants
n=206 Participants
Cannabis Use Per Day
3 - 4 Times Per Day
15 Participants
n=99 Participants
10 Participants
n=107 Participants
25 Participants
n=206 Participants
Cannabis Use Per Day
5 or More Times Per Day
3 Participants
n=99 Participants
4 Participants
n=107 Participants
7 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 16 Weeks

The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. The range of the ISI is 0 to 28, with 28 corresponding to maximum severity.

Outcome measures

Outcome measures
Measure
Cognitive Behavioral Therapy for Insomnia in Cannabis Users (CBTi-CB)
n=30 Participants
Each CBTi-CB therapy session reviewed the previous week of sleep/wake diaries and summarized key sleep parameters with participants. The treatment addressed cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content included: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Sleep Hygiene Education (SHE)
n=27 Participants
The SHE condition was matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The content included: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
Change From Baseline Insomnia Severity Index Score at Study Completion
Longitudinal Model estimates at 8-week Follow-up
11.2 units on a scale
Standard Error 0.8
12.6 units on a scale
Standard Error 0.8
Change From Baseline Insomnia Severity Index Score at Study Completion
Longitudinal Model estimates at 16-week Follow-up
6.0 units on a scale
Standard Error 1.1
8.8 units on a scale
Standard Error 1.0

Adverse Events

CBTi-CB

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sleep Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Ilgen

University of Michigan

Phone: 734-845-3646

Results disclosure agreements

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