The Effect of Prescription Medications in Marijuana Users

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Vandrey R, Stitzer ML, Mintzer MZ, Huestis MA, Murray JA, Lee D. The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Drug Alcohol Depend. 2013 Feb 1;128(1-2):64-70. doi: 10.1016/j.drugalcdep.2012.08.001. Epub 2012 Aug 22.

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

Lee D, Vandrey R, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid cannabinoids in chronic frequent cannabis smokers during ad libitum cannabis smoking. Drug Test Anal. 2015 Jun;7(6):494-501. doi: 10.1002/dta.1718. Epub 2014 Sep 14.

Lee D, Vandrey R, Milman G, Bergamaschi M, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid/plasma cannabinoid ratios following controlled oral THC and smoked cannabis administration. Anal Bioanal Chem. 2013 Sep;405(23):7269-79. doi: 10.1007/s00216-013-7159-8. Epub 2013 Jul 6.

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
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