The Role of Sleep in the Treatment of Cannabis Use Disorders

• 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: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: September 11, 2012
• First Posted Date: September 13, 2012
• Results First Submitted Date: May 1, 2019
• Results First Posted Date: May 22, 2019
• Last Update Posted Date: May 22, 2019
• Study Start Date: September 2012
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 21, 2019)

• Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed [ Time Frame: 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 [ Time Frame: Week 12 ]
  Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.

Original Primary Outcome Measures (submitted: September 12, 2012)

• Sleep Efficiency [ Time Frame: up to 24 Weeks ]
  Sleep will be objectively measured at 5 time points during the study assessment period using ambulatory polysomnography (PSG) equipment.
• Cannabis Abstinence [ Time Frame: Twice weekly on Weeks 1-12; Week 24 and 36 ]
  Urine drug testing will determine whether study participants are abstinent from cannabis use throughout participation in treatment (12 weeks) and at 3- and 6-month follow-up assessments

• Change History: Complete list of historical versions of study NCT01685073 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Sleep in the Treatment of Cannabis Use Disorders
• Official Title: The Role of Sleep in the Treatment of Cannabis Use Disorders
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Drug Addiction

Intervention

• Drug: Zolpidem extended-release
  nightly administration of zolpidem extended-release
  Other Name: Ambien CR
• Behavioral: 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

Study Arms

• Experimental: Zolpidem
  Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
  Interventions:

  • Drug: Zolpidem extended-release
  • Behavioral: MET/CBT
• Placebo Comparator: Placebo
  Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
  Intervention: Behavioral: MET/CBT

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2018): 127
• Original Estimated Enrollment (submitted: September 12, 2012): 100
• Actual Study Completion Date: July 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01685073
• Other Study ID Numbers: NA_00068969; U01DA031784 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Johns Hopkins University
• Study Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Ryan Vandrey, PhD; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: May 2019