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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Dronabinol; Pharmaceutical Solutions

Criteria

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