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

December 3, 2013 updated by: Ryan Vandrey, Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Medication
Participants receive active hypnotic medication prior to sleep
Drug: eszopiclone
Oral capsule at dose recommended for adults
Drug: ramelteon
ramelteon
Drug: zolpidem
zolpidem
Placebo Comparator: Placebo
Participants receive placebo prior to sleep
Drug: Placebo
Participants receive placebo prior to sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Marijuana Withdrawal
Time Frame: Every day during study participation
Every day during study participation

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Sleep Assessment
Time Frame: Every day during study participation
Every day during study participation
Cognitive Performance
Time Frame: Every day during study participation
Every day during study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Investigators

  • Principal Investigator: Ryan Vandrey, Ph.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00017909
  • R21DA025794 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Marijuana Dependence

Clinical Trials on eszopiclone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe