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Trial record 9 of 120 for:    ZOLPIDEM AND AIDS

The Role of Sleep in the Treatment of Cannabis Use Disorders

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ClinicalTrials.gov Identifier: NCT01685073
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Drug Addiction
Interventions Drug: Zolpidem extended-release
Behavioral: MET/CBT
Enrollment 127
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zolpidem Placebo
Hide 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 [1] 65 [1]
Completed 32 [2] 33 [2]
Not Completed 30 32
Reason Not Completed
Lost to Follow-up             6             8
Withdrawal by Subject             24             24
[1]
Randomized
[2]
Retained in treatment through 12 weeks
Arm/Group Title Zolpidem Placebo Total
Hide 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 Number of Baseline Participants 62 65 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 65 participants 127 participants
31  (9) 32  (9) 31  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 participants
Female
25
  40.3%
23
  35.4%
48
  37.8%
Male
37
  59.7%
42
  64.6%
79
  62.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 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%
0
   0.0%
Tobacco Smoking Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 participants
36
  58.1%
36
  55.4%
72
  56.7%
[1]
Measure Description: Tobacco smoking status count was for participants who answered YES to tobacco smoking
1.Primary Outcome
Title Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
Hide Description Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
Time Frame Week 1 of treatment
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 50 51
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem Placebo
Hide 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

Overall Number of Participants Analyzed 62 65
Measure Type: Count of Participants
Unit of Measure: Participants
Negative urine test
17
  27.4%
10
  15.4%
Positive urine test
45
  72.6%
55
  84.6%
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Placebo
Hide 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 (%) Affected / at Risk (%)
Total   0/62 (0.00%)      0/65 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/62 (3.23%)      0/65 (0.00%)    
Infections and infestations     
Urinary tract infection *  1/62 (1.61%)  1 0/65 (0.00%) 
Vascular disorders     
Stroke, cerebrovascular accident *  1/62 (1.61%)  1 0/65 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zolpidem Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/62 (48.39%)      35/65 (53.85%)    
Gastrointestinal disorders     
nausea *  7/62 (11.29%)  7 7/65 (10.77%)  7
emesis *  6/62 (9.68%)  6 6/65 (9.23%)  6
General disorders     
toothache *  5/62 (8.06%)  5 3/65 (4.62%)  3
Headache *  4/62 (6.45%)  4 5/65 (7.69%)  5
Cold symptoms *  6/62 (9.68%)  6 9/65 (13.85%)  9
Sleep Difficulties *  2/62 (3.23%)  2 5/65 (7.69%)  5
*
Indicates events were collected by non-systematic assessment
There was a significant number of participant drop-outs in both study arms
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ryan Vandrey, PhD
Organization: Johns Hopkins University
Phone: 410-550-4036
EMail: rvandrey@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01685073     History of Changes
Other Study ID Numbers: NA_00068969
U01DA031784 ( U.S. NIH Grant/Contract )
First Submitted: September 11, 2012
First Posted: September 13, 2012
Results First Submitted: May 1, 2019
Results First Posted: May 22, 2019
Last Update Posted: May 22, 2019