Effects of Dronabinol (Oral THC) on Cannabis Use

Phase 1

Completed

• Conditions: Marijuana Smoking
• Interventions: Drug: Dronabinol 120mg/day; Drug: Placebo; Drug: Dronabinol 240mg/day

• Registration Number: NCT01394185
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2017-04-18
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Results First Posted: 2017-08-03
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Dose Dronabinol, High Dose Dronabinol, and placebo	Dronabinol 120mg/day	Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order
Low Dose Dronabinol, High Dose Dronabinol, and placebo	Dronabinol 240mg/day	Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order
Low Dose Dronabinol, High Dose Dronabinol, and placebo	Placebo	Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order

Primary Outcome Measures

Name	Time	Method
Marijuana Self-administration - Progressive Ratio	12-day Dronabinol maintenance period	Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint
Marijuana Self-administration - Drug Vs Money Choice	12-day Dronabinol maintenance period	Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint

Trial Locations

Locations (1)

Johns Hopkins University (Bayview Campus); 🇺🇸 Baltimore, Maryland, United States