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

NCT02094599 | Completed Phase 1

• 1 other identifier: INS-13-017
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Abuse, Medication

Outcome Measures

Primary Outcomes (1)

• Peak score (Emax) on Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking

  within 24 hours post-dose

Secondary Outcomes (11)

• Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely

  within 24 hours post-dose

• Peak score (Emax) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score

  within 24 hours post-dose

• Peak score (Emax) for Subjective Drug Value (SDV) in dollars

  within 24 hours post-dose

• Time-averaged Area under the Effect Curve (TA_AUC) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely

  within 24 hours post-dose

• Overall Drug Liking (Emax/Emin) calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking

  within 24 hours post-dose

Study Arms (1)

All Enrolled Participants

EXPERIMENTAL

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.

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

Interventions

Dronabinol 10 mg DRUG

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

All Enrolled Participants

Dronabinol 30 mg DRUG

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

All Enrolled Participants

Placebo DRUG

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

All Enrolled Participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (1)

INC Research Toronto, Inc.

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Larry Dillaha, MD

  INSYS Therapeutics Inc

  STUDY DIRECTOR

• Michael McDonnell, MD

  INC Research Toronto, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 24, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)