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| ID | Type | Description | Link |
|---|---|---|---|
| U01DA031784 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem | Experimental | Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder |
|
| Placebo | Placebo Comparator | Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem extended-release | Drug | nightly administration of zolpidem extended-release |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28782982 | Derived | Pacek LR, Herrmann ES, Smith MT, Vandrey R. Sleep continuity, architecture and quality among treatment-seeking cannabis users: An in-home, unattended polysomnographic study. Exp Clin Psychopharmacol. 2017 Aug;25(4):295-302. doi: 10.1037/pha0000126. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of time asleep while in bed | Week 1 of treatment |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke, cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| toothache | General disorders | Non-systematic Assessment |
There was a significant number of participant drop-outs in both study arms
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | 410-550-4036 | rvandrey@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2015 | May 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D002189 | Marijuana Abuse |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| MET/CBT | Behavioral | 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 |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Tobacco Smoking Status | Tobacco smoking status count was for participants who answered YES to tobacco smoking | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 62 |
| 2 |
| 62 |
| 30 |
| 62 |
| EG001 | 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 | 0 | 65 | 0 | 65 | 35 | 65 |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Cold symptoms | General disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sleep Difficulties | General disorders | Non-systematic Assessment |
|
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |