Marijuana Abuse | The Effect of Prescription Medications in Marijuana Users
Marijuana Abuse research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Dronabinol 30mg/day10mg dronabinol administered 3x/day for 5 days
Drug:Dronabinol 60mg/day20mg dronabinol administered 3x/day for 5 days
Drug:Dronabinol 120mg/day40mg dronabinol administered 3x/day for 5 days
Drug:Placeboplacebo dronabinol administered 3x/day for 5 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
0, 30, 60, and 120mg dronabinol0, 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
Start Date: April 2009
Completed Date: October 2011
Phase: Phase 1/Phase 2
Primary Outcome: Peak Effect of Marijuana Withdrawal
Secondary Outcome: Heart Rate
Study sponsors, principal investigator, and references
Principal Investigator: Ryan Vandrey, Ph.D.
Lead Sponsor: Johns Hopkins University
Collaborator: National Institute on Drug Abuse (NIDA)
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.