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The Effect of Prescription Medications in Marijuana Users
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00893074
First received: April 30, 2009
Last updated: August 2, 2017
Last verified: August 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Marijuana Abuse | Drug: Dronabinol 30mg/day Drug: Dronabinol 60mg/day Drug: Dronabinol 120mg/day Drug: Placebo | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Heart Rate [ Time Frame: Assessed on Day 5 of dronabinol maintenance ]Heart rate measured after acute cannabis exposure
| Enrollment: | 24 |
| Study Start Date: | April 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893074
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
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 ) |
| Study First Received: | April 30, 2009 |
| Results First Received: | April 18, 2017 |
| Last Updated: | August 2, 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 |
ClinicalTrials.gov processed this record on September 21, 2017