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

NCT ID: NCT02094599

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

Brief Summary

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

Detailed 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.

Conditions

Drug Abuse, Medication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: TRIPLE

Study Groups

All Enrolled Participants

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.

Group Type: EXPERIMENTAL

Dronabinol 10 mg

Intervention Type: DRUG

Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.

Dronabinol 30 mg

Intervention Type: DRUG

Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.

Placebo

Intervention Type: DRUG

Matching placebo provided in capsules or as an oral solution in syringes.

Interventions

Dronabinol 10 mg

Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.

Intervention Type: DRUG

Dronabinol 30 mg

Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.

Intervention Type: DRUG

Placebo

Matching placebo provided in capsules or as an oral solution in syringes.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

INSYS Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Dillaha, MD

Role: STUDY_DIRECTOR

INSYS Therapeutics Inc

Michael McDonnell, MD

Role: PRINCIPAL_INVESTIGATOR

INC Research Toronto, Inc.

Locations

INC Research Toronto, Inc.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

INS-13-017

Identifier Type: -

Identifier Source: org_study_id