NCT01685073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 22, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

September 11, 2012

Results QC Date

May 1, 2019

Last Update Submit

May 21, 2019

Conditions

Drug Addiction

Keywords

marijuanacannabistreatmentinsomniarelapse

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Zolpidem

EXPERIMENTAL

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

Drug: Zolpidem extended-releaseBehavioral: MET/CBT

Placebo

PLACEBO COMPARATOR

Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder

Behavioral: MET/CBT

Interventions

Zolpidem extended-releaseDRUG

nightly administration of zolpidem extended-release

Also known as: Ambien CR
Zolpidem
MET/CBTBEHAVIORAL

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

PlaceboZolpidem

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 28782982DERIVED

MeSH Terms

Conditions

Substance-Related DisordersMarijuana AbuseSleep Initiation and Maintenance DisordersRecurrence

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

There was a significant number of participant drop-outs in both study arms

Results Point of Contact

Title
Ryan Vandrey, PhD
Organization
Johns Hopkins University
rvandrey@jhmi.edu
410-550-4036

Study Officials

  • Ryan Vandrey, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 22, 2019

Results First Posted

May 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)