The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

NCT ID: NCT00893269

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-10-31

Brief Summary

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Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.

Detailed Description

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Conditions

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Marijuana Dependence

Keywords

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marijuana cannabis dependence withdrawal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Medication

Participants receive active hypnotic medication prior to sleep

Group Type EXPERIMENTAL

eszopiclone

Intervention Type DRUG

Oral capsule at dose recommended for adults

ramelteon

Intervention Type DRUG

ramelteon

zolpidem

Intervention Type DRUG

zolpidem

Placebo

Participants receive placebo prior to sleep

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants receive placebo prior to sleep

Interventions

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eszopiclone

Oral capsule at dose recommended for adults

Intervention Type DRUG

Placebo

Participants receive placebo prior to sleep

Intervention Type DRUG

ramelteon

ramelteon

Intervention Type DRUG

zolpidem

zolpidem

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* current use of marijuana
* able to give informed consent

Exclusion Criteria

* dependence on drug other than marijuana
* current sleep disorder
* pregnant, breast feeding, or planning to become pregnant within the next 3 months
* currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
* use of cannabis under the guidance of a physician for a medical disorder
* unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
* allergy to study medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Ryan Vandrey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Vandrey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.

Reference Type DERIVED
PMID: 21359104 (View on PubMed)

Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.

Reference Type DERIVED
PMID: 21296508 (View on PubMed)

Other Identifiers

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R21DA025794

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00017909

Identifier Type: -

Identifier Source: org_study_id