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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Marijuana Abuse Drug: Dronabinol 30mg/day Drug: Dronabinol 60mg/day Drug: Dronabinol 120mg/day Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Official Title: The Effect of Prescription Medications in Marijuana Users
Study Start Date : April 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Dronabinol

Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: Assessed on Day 5 of dronabinol maintenance ]
    Heart rate measured after acute cannabis exposure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893074


Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00893074     History of Changes
Other Study ID Numbers: NA_00026278
R01DA025044 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2009    Key Record Dates
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
withdrawal
acute effects
cognitive performance
Marijuana Use
Marijuana Abstinence

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists