Phase 2 N=25 Randomized Double-blind Basic Science

Effects of Dronabinol (Oral THC) on Cannabis Use

Marijuana Smoking

Bottom Line

View on ClinicalTrials.gov: NCT01394185 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Marijuana Self-administration - Progressive Ratio — 5.2; 4.5; 4.4 Progressive Ratios Completed

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dronabinol 120mg/day (Drug); Placebo (Drug); Dronabinol 240mg/day (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Marijuana Self-administration - Progressive Ratio	5.2; 4.5; 4.4	—
PRIMARY Marijuana Self-administration - Drug Vs Money Choice	3.5; 2.3; 2.5	—

Summary

Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

Eligibility Criteria

Inclusion Criteria

Current use of marijuana
Able to give informed consent

Exclusion Criteria

Daily use of psychoactive medication
Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
Uncontrolled or unstable cardiovascular disease
Allergy to sesame oil

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01394185). 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.