A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users

INSYS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Drug Abuse, Medication

Treatments: Drug: Dronabinol 10 mg; Drug: Dronabinol 30 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094599

INS-13-017

Details and patient eligibility

About

The primary objective of this study is to evaluate the abuse potential of dronabinol oral solution in recreational cannabinoid users.

Full description

Following a four-day period for screening and qualification, there are five treatment visits with a minimum 8-day washout between treatments. Each participant will receive all treatments in a 5-way crossover design.

Enrollment: 43 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult protocol-defined recreational cannabinoid user
• Meets protocol-specified criteria for qualification and contraception
• Able to speak, read and understand English well enough to understand the nature of the study, provide written informed consent, and to allow completion of all study assessments
• Provides written informed consent prior to any protocol-specific procedures, and agrees to abide by all protocol-specified requirements and restrictions

Exclusion criteria

• Dependence on any substance other than nicotine or caffeine beyond protocol-specified limits
• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), 3) the analysis of results
• Unwilling, unable, or unlikely to follow protocol-specified restrictions on food, drink, nicotine or physical activities (such as exercise and driving)
• An employee of the sponsor or research site personnel directly affiliated with this study or their immediate biological or adopted family member defined as a spouse, parent, child or sibling

Trial design

43 participants in 1 patient group

All Enrolled Participants

Experimental group

Description:

Each participant receives all treatments (of placebo, dronabinol 10 mg and dronabinol 30 mg) in a 5-way crossover design. At each treatment visit, participants receive a single dose, contained in two syringes of oral solution and three capsules. When dronabinol is in syringes, placebo is in capsules, and when dronabinol is in capsules, placebo is in syringes. When assigned to take placebo only, placebo is in both the syringes and the capsules.

Treatment:

Drug: Dronabinol 30 mg

Drug: Placebo

Drug: Dronabinol 10 mg