Drug AddictionPhase 2/3NCT01685073

The Role of Sleep in the Treatment of Cannabis Use Disorders

A Phase 2/3 study testing Zolpidem extended-release and MET/CBT in people with Drug Addiction, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Drug Addiction
What is being tested?: Zolpidem extended-release and MET/CBT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jul 2018
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-55 years.
Recent problematic use of cannabis
Cannabis use impacts sleep

Who cannot join

Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
Moderate sleep apnea or periodic limb movement disorder
Pregnant, breast feeding, or planning to become pregnant within the next 3 months
Current condition associated with severe cognitive/social impairment
Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem
Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment
Current use of hypnotic medications

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins University
Baltimore, Maryland, 21224

Other trials in United States

About this study

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.

Conditions: Drug Addiction
Being tested: Zolpidem extended-release, MET/CBT
Keywords: marijuana, cannabis, treatment, insomnia, relapse
Medical subject headings: Substance-Related Disorders, Marijuana Abuse, Sleep Initiation and Maintenance Disorders, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zolpidem extended-releaseDrug
Also called Ambien CR
nightly administration of zolpidem extended-release
MET/CBTBehavioural
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 groups in NCT01685073
Study group	Role	What they receive
Zolpidem	Experimental	Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder Receives: Drug: Zolpidem extended-release; Behavioral: MET/CBT
Placebo	Placebo comparator	Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder Receives: Behavioral: MET/CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jul 2018

First posted13 Sep 2012 (estimated)
Study startSep 2012
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Drug AddictionStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01685073
Sponsor's protocol ID: NA_00068969
Other IDs: U01DA031784
Status last verified: May 2019
First submitted: 11 Sep 2012
Last updated: 22 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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.
PubMed 28782982

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Sleep in the Treatment of Cannabis Use Disorders
ClinicalTrials.gov ID: NCT01685073
Acronym / sponsor ID: NA_00068969
Conditions: Drug Addiction
Keywords: marijuana, cannabis, treatment, insomnia, relapse
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2012
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 13 Sep 2012 (estimated)
Results: Posted 22 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Zolpidem	Experimental	Drug: Zolpidem extended-release, Behavioral: MET/CBTParticipants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
Placebo	Placebo comparator	Behavioral: MET/CBTParticipants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age 18-55 years.
Recent problematic use of cannabis
Cannabis use impacts sleep

Key exclusion criteria (7 listed)

Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
Moderate sleep apnea or periodic limb movement disorder
Pregnant, breast feeding, or planning to become pregnant within the next 3 months
Current condition associated with severe cognitive/social impairment
Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zolpidem extended-releaseAlso: Ambien CRnightly administration of zolpidem extended-release	Drug	Zolpidem
MET/CBTa 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	Behavioural	Placebo, Zolpidem

Primary outcome

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.

Results and safety

Results posted to the registry on 22 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zolpidem	62	32
Placebo	65	33

Primary outcome: Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed

Time frame: Week 1 of treatment. Mean (Standard Deviation). Unit: percentage of time asleep while in bed

Measure	Zolpidem n = 50	Placebo n = 51
Value	78 (16)	74 (19)

Population analysed: 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.

Primary outcome: Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing

Time frame: Week 12. Count of participants. Unit: Participants

Measure	Zolpidem n = 62	Placebo n = 65
Negative urine test	17	10
Positive urine test	45	55

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zolpidem	2 of 62 (3.2%)	30 of 62 (48.4%)	0 of 62
Placebo	0 of 65 (0%)	35 of 65 (53.8%)	0 of 65

Limitations and caveats (from the sponsor): There was a significant number of participant drop-outs in both study arms

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28782982Pacek 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan Vandrey, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Zolpidem extended-release and MET/CBT in people with Drug Addiction, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed (time frame: Week 1 of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.