Phase 2 N=24 Randomized Double-blind Basic Science

The Effect of Prescription Medications in Marijuana Users

Marijuana Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00893074 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Peak Effect of Marijuana Withdrawal — 4.6; 4.1; 2.9; 1.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dronabinol 30mg/day (Drug); Dronabinol 60mg/day (Drug); Dronabinol 120mg/day (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Effect of Marijuana Withdrawal	4.6; 4.1; 2.9; 1.7	—
PRIMARY Subjective "Drug Effect" After Smoked Marijuana	23; 28; 24; 29	—
SECONDARY Heart Rate	88; 85; 80; 76	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00893074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.