A Phase 2/3 interventional study of Zolpidem extended-release and MET/CBT in Drug Addiction, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 127 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Drug: Zolpidem extended-release · Behavioral: MET/CBT
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
Behavioral: MET/CBT
nightly administration of zolpidem extended-release
Also known as: Ambien CR
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
Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Time frame: Week 1 of treatment
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
| Milestone | Zolpidem | Placebo |
|---|---|---|
| Started | 62 | 65 |
| Completed | 32 | 33 |
| Not completed | 30 | 32 |
| Withdrew: Lost to follow-up | 6 | 8 |
| Withdrew: Withdrawal by subject | 24 | 24 |
Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
| percentage of time asleep while in bed | Zolpidem | Placebo |
|---|---|---|
| Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed | 78 ± 16 | 74 ± 19 |
Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH \<50ng/mL via EIA.
| Participants | Zolpidem | Placebo |
|---|---|---|
| Negative urine test | 17 | 10 |
| Positive urine test | 45 | 55 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zolpidem | 0/62 (0%) | 2/62 (3.2%) | 30/62 (48.4%) |
| Placebo | 0/65 (0%) | 0/65 (0%) | 35/65 (53.8%) |
| Event | Zolpidem | Placebo |
|---|---|---|
| Stroke, cerebrovascular accidentVascular disorders | 1/62 | 0/65 |
| Urinary tract infectionInfections and infestations | 1/62 | 0/65 |
| Event | Zolpidem | Placebo |
|---|---|---|
| Cold symptomsGeneral disorders | 6/62 | 9/65 |
| nauseaGastrointestinal disorders | 7/62 | 7/65 |
| emesisGastrointestinal disorders | 6/62 | 6/65 |
| toothacheGeneral disorders | 5/62 | 3/65 |
| HeadacheGeneral disorders | 4/62 | 5/65 |
| Sleep DifficultiesGeneral disorders | 2/62 | 5/65 |
| Age, Continuous(years) | Zolpidem | Placebo | Total |
|---|---|---|---|
| Mean | 31 ± 9 | 32 ± 9 | 31 ± 9 |
| Sex: Female, Male(Participants) | Zolpidem | Placebo | Total |
|---|---|---|---|
| Female | 25 | 23 | 48 |
| Male | 37 | 42 | 79 |
| Ethnicity (NIH/OMB)(Participants) | Zolpidem | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 57 | 63 | 120 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Tobacco Smoking Status(Participants) | Zolpidem | Placebo | Total |
|---|---|---|---|
| Count of participants | 36 | 36 | 72 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University