Clinical trial NCT00893074: The Effect of Prescription Medications in Marijuana Users
Official title: The Effect of Prescription Medications in Marijuana Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Marijuana Abuse
Keywords: withdrawal
acute effects
cognitive performance
Marijuana Use
Marijuana Abstinence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Peak Effect of Marijuana Withdrawal
timeFrame: Day 5 of the Dronabinol abstinence period
measure: Subjective "Drug Effect" After Smoked Marijuana
timeFrame: Day 5 of the Dronabinol abstinence period
Secondary outcomes:
measure: Heart Rate
timeFrame: Assessed on Day 5 of dronabinol maintenance
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ryan Vandrey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schlienz NJ, Lee DC, Stitzer ML, Vandrey R. The effect of high-dose dronabinol (oral THC) maintenance on cannabis self-administration. Drug Alcohol Depend. 2018 Jun 1;187:254-260. doi: 10.1016/j.drugalcdep.2018.02.022. Epub 2018 Apr 17.
citation: 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.
citation: 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.