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OpenTrials
Completed

NCT Number: NCT00893269

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

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.

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Key information

Conditions

Marijuana Dependence Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone

Drug

Oral capsule at dose recommended for adults

Placebo

Drug

Participants receive placebo prior to sleep

Ramelteon

Drug

ramelteon

zolpidem

Drug

zolpidem

Primary outcomes

  1. Marijuana Withdrawal

    Time frame: Every day during study participation

Secondary outcomes

  1. Objective Sleep Assessment

    Time frame: Every day during study participation

  2. Cognitive Performance

    Time frame: Every day during study participation

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 5, 2009
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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