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Trial record 12 of 120 for:    ZOLPIDEM AND AIDS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00893269
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : December 5, 2013
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 5, 2009
Last Update Posted Date December 5, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
Marijuana Withdrawal [ Time Frame: Every day during study participation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00893269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
  • Objective Sleep Assessment [ Time Frame: Every day during study participation ]
  • Cognitive Performance [ Time Frame: Every day during study participation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Official Title  ICMJE The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Marijuana Dependence
Intervention  ICMJE
  • Drug: eszopiclone
    Oral capsule at dose recommended for adults
  • Drug: Placebo
    Participants receive placebo prior to sleep
  • Drug: ramelteon
    ramelteon
  • Drug: zolpidem
    zolpidem
Study Arms  ICMJE
  • Experimental: Active Medication
    Participants receive active hypnotic medication prior to sleep
    Interventions:
    • Drug: eszopiclone
    • Drug: ramelteon
    • Drug: zolpidem
  • Placebo Comparator: Placebo
    Participants receive placebo prior to sleep
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2009)
35
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00893269
Other Study ID Numbers  ICMJE NA_00017909
R21DA025794 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ryan Vandrey, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP