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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00893269
Enrollment
36
Registered
2009-05-05
Start date
2008-10-31
Completion date
2010-10-31
Last updated
2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Dependence

Keywords

marijuana, cannabis, dependence, withdrawal

Brief summary

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.

Interventions

DRUGeszopiclone

Oral capsule at dose recommended for adults

DRUGPlacebo

Participants receive placebo prior to sleep

DRUGramelteon

ramelteon

DRUGzolpidem

zolpidem

Sponsors

Food and Drug Administration (FDA)
CollaboratorFED
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Marijuana WithdrawalEvery day during study participation

Secondary

MeasureTime frame
Objective Sleep AssessmentEvery day during study participation
Cognitive PerformanceEvery day during study participation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026