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.

Study Overview

• Status: Completed
• Conditions: Drug Abuse, Medication
• Intervention / Treatment: Drug: Dronabinol 10 mg; Drug: Dronabinol 30 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 2T3
      • INC Research Toronto, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: Dronabinol 10 mg; Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.; Drug: Dronabinol 30 mg; Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.; Drug: Placebo; Matching placebo provided in capsules or as an oral solution in syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely	Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects	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	Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana	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	Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects	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
Time-averaged Area under the Effect Curve (TA_AUC) for Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking		within 24 hours post-dose
Time-averaged Area under the Effect Curve (TA_AUC) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score	Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana	within 24 hours post-dose
Trough Score (Emin) for Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking		within 24 hours post-dose
Peak score (Emax) for Take Drug Again, calculated from scores on a VAS scale of 0-100, where 0=definitely not and 100=definitely so		within 24 hours post-dose
Peak score (Emax) for Alertness/Drowsiness, calculated from scores on a VAS scale of 0-100, where 0=very drowsy and 100=very alert		within 24 hours post-dose
Time-averaged Area under the Effect Curve (TA_AUC) for Alertness/Drowsiness, calculated from a 100-point visual analogue scale (VAS), where 0=very drowsy and 100=very alert		within 24 hours post-dose

Collaborators and Investigators

• Sponsor: INSYS Therapeutics Inc
• Investigators: Study Director: Larry Dillaha, MD, INSYS Therapeutics Inc; Principal Investigator: Michael McDonnell, MD, INC Research Toronto, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (ESTIMATE): March 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: INS-13-017