Drug Addiction
Conditions
Keywords
marijuana, cannabis, treatment, insomnia, relapse
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.
Interventions
DRUGZolpidem extended-release
nightly administration of zolpidem extended-release
BEHAVIORALMET/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
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 62 |
| 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 | 65 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Withdrawal by Subject | 24 | 24 |
Baseline characteristics
| Characteristic | Zolpidem | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 9 | 32 years STANDARD_DEVIATION 9 | 31 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 63 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 37 Participants | 42 Participants | 79 Participants |
| Tobacco Smoking Status | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 65 |
| other Total, other adverse events | 30 / 62 | 35 / 65 |
| serious Total, serious adverse events | 2 / 62 | 0 / 65 |
Outcome results
Primary
Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH \<50ng/mL via EIA.
Time frame: Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zolpidem | Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing | Negative urine test | 17 Participants |
| Zolpidem | Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing | Positive urine test | 45 Participants |
| Placebo | Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing | Negative urine test | 10 Participants |
| Placebo | Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing | Positive urine test | 55 Participants |
Primary
Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zolpidem | Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed | 78 percentage of time asleep while in bed | Standard Deviation 16 |
| Placebo | Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed | 74 percentage of time asleep while in bed | Standard Deviation 19 |