The Effect of Prescription Medications in Marijuana Users
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
August 3, 2017
CompletedAugust 3, 2017
August 1, 2017
2.5 years
April 30, 2009
April 18, 2017
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Peak Effect of Marijuana Withdrawal
Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).
Day 5 of the Dronabinol abstinence period
Subjective "Drug Effect" After Smoked Marijuana
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
Day 5 of the Dronabinol abstinence period
Secondary Outcomes (1)
Heart Rate
Assessed on Day 5 of dronabinol maintenance
Study Arms (1)
0, 30, 60, and 120mg dronabinol
OTHER0, 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
Interventions
10mg dronabinol administered 3x/day for 5 days
20mg dronabinol administered 3x/day for 5 days
40mg dronabinol administered 3x/day for 5 days
Eligibility Criteria
You may qualify if:
- current use of marijuana
- able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224, United States
Related Publications (4)
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.
PMID: 22921474RESULTSchlienz 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.
PMID: 29689485DERIVEDLee 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.
PMID: 25220020DERIVEDLee 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.
PMID: 23831756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Vandrey, PhD
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Vandrey, Ph.D.
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Dronbinol doses were double blind and placebo controlled
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 5, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 3, 2017
Results First Posted
August 3, 2017
Record last verified: 2017-08