Effects of Dronabinol (Oral THC) on Cannabis Use

Johns Hopkins University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Marijuana Smoking

Treatments: Drug: Dronabinol 240mg/day; Drug: Dronabinol 120mg/day; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01394185

NA_00041251

R01DA025044 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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25 participants in 1 patient group

Low Dose Dronabinol, High Dose Dronabinol, and placebo

Active Comparator group

Description:

Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order

Treatment:

Drug: Placebo

Drug: Dronabinol 120mg/day

Drug: Dronabinol 240mg/day