The Effect of Prescription Medications in Marijuana Users

NCT ID: NCT00893074

Last Updated: 2017-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Marijuana Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Dronbinol doses were double blind and placebo controlled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Dronabinol 30mg/day

Intervention Type DRUG

10mg dronabinol administered 3x/day for 5 days

Dronabinol 60mg/day

Intervention Type DRUG

20mg dronabinol administered 3x/day for 5 days

Dronabinol 120mg/day

Intervention Type DRUG

40mg dronabinol administered 3x/day for 5 days

Placebo

Intervention Type DRUG

placebo dronabinol administered 3x/day for 5 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dronabinol 30mg/day

10mg dronabinol administered 3x/day for 5 days

Intervention Type DRUG

Dronabinol 60mg/day

20mg dronabinol administered 3x/day for 5 days

Intervention Type DRUG

Dronabinol 120mg/day

40mg dronabinol administered 3x/day for 5 days

Intervention Type DRUG

Placebo

placebo dronabinol administered 3x/day for 5 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

THC Marinol THC Marinol THC Marinol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan Vandrey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22921474 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29689485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25220020 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23831756 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA025044

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00026278

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antagonist-Elicited Cannabis Withdrawal
NCT01041170 COMPLETED PHASE1
Cannabidiol and Cannabis Concentrate Users
NCT06575751 RECRUITING PHASE2
Nabilone for Cannabis Dependence: A Pilot Study
NCT01347762 COMPLETED PHASE2/PHASE3