The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 5, 2013
December 1, 2013
2 years
April 30, 2009
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Marijuana Withdrawal
Every day during study participation
Secondary Outcomes (2)
Objective Sleep Assessment
Every day during study participation
Cognitive Performance
Every day during study participation
Study Arms (2)
Active Medication
EXPERIMENTALParticipants receive active hypnotic medication prior to sleep
Placebo
PLACEBO COMPARATORParticipants receive placebo prior to sleep
Interventions
Eligibility Criteria
You may qualify if:
- current use of marijuana
- able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Food and Drug Administration (FDA)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Related Publications (2)
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.
PMID: 21359104DERIVEDVandrey 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.
PMID: 21296508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Vandrey, Ph.D.
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 5, 2009
Study Start
October 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 5, 2013
Record last verified: 2013-12