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The Effect of Prescription Medications in Marijuana Users

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ClinicalTrials.gov Identifier: NCT00893074
Recruitment Status : Completed
First Posted : May 5, 2009
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

April 30, 2009
May 5, 2009
April 18, 2017
August 3, 2017
August 3, 2017
April 2009
October 2011   (Final data collection date for primary outcome measure)
  • Peak Effect of Marijuana Withdrawal [ Time Frame: Day 5 of the Dronabinol abstinence period ]
    Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).
  • Subjective "Drug Effect" After Smoked Marijuana [ Time Frame: Day 5 of the Dronabinol abstinence period ]
    Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect
  • marijuana withdrawal [ Time Frame: Every day during study participation ]
  • subjective effects of smoked marijuana [ Time Frame: Every 5-9 days ]
Complete list of historical versions of study NCT00893074 on ClinicalTrials.gov Archive Site
Heart Rate [ Time Frame: Assessed on Day 5 of dronabinol maintenance ]
Heart rate measured after acute cannabis exposure
cognitive performance [ Time Frame: Every 5-9 days ]
Not Provided
Not Provided
 
The Effect of Prescription Medications in Marijuana Users
The Effect of Prescription Medications in Marijuana Users
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Within-subjects cross-over evaluation of 0, 30, 60, and 120mg dronabinol per day on withdrawal, cognitive performance, and response to acute cannabis exposure
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Dronbinol doses were double blind and placebo controlled
Primary Purpose: Basic Science
Marijuana Abuse
  • Drug: Dronabinol 30mg/day
    10mg dronabinol administered 3x/day for 5 days
    Other Names:
    • THC
    • Marinol
  • Drug: Dronabinol 60mg/day
    20mg dronabinol administered 3x/day for 5 days
    Other Names:
    • THC
    • Marinol
  • Drug: Dronabinol 120mg/day
    40mg dronabinol administered 3x/day for 5 days
    Other Names:
    • THC
    • Marinol
  • Drug: Placebo
    placebo dronabinol administered 3x/day for 5 days
0, 30, 60, and 120mg dronabinol
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
Interventions:
  • Drug: Dronabinol 30mg/day
  • Drug: Dronabinol 60mg/day
  • Drug: Dronabinol 120mg/day
  • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
21
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • current use of marijuana
  • able to give informed consent

Exclusion Criteria:

  • dependence on drug other than marijuana
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00893074
NA_00026278
R01DA025044 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
Johns Hopkins University
August 2017

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