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

A Single-dose, Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of Dronabinol Oral Solution in Recreational Cannabinoid Users

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

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.

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