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
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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 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 |

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
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Drug: Dronabinol 30mg/day
10mg dronabinol administered 3x/day for 5 days
Other Names:
Drug: Dronabinol 60mg/day
20mg dronabinol administered 3x/day for 5 days
Other Names:
Drug: Dronabinol 120mg/day
40mg dronabinol administered 3x/day for 5 days
Other Names:
Drug: Placebo
placebo dronabinol administered 3x/day for 5 days
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- 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
- Heart Rate [ Time Frame: Assessed on Day 5 of dronabinol maintenance ]Heart rate measured after acute cannabis exposure

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Maryland | |
Behavioral Pharmacology Research Unit | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Ryan Vandrey, Ph.D. | Johns Hopkins University |
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 |