Clinical trial NCT02094599: A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Abuse, Medication
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Peak score (Emax) on Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
timeFrame: within 24 hours post-dose
Secondary outcomes:
measure: Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely
timeFrame: within 24 hours post-dose
measure: Peak score (Emax) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score
timeFrame: within 24 hours post-dose
measure: Peak score (Emax) for Subjective Drug Value (SDV) in dollars
timeFrame: within 24 hours post-dose
measure: 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
timeFrame: within 24 hours post-dose
measure: Overall Drug Liking (Emax/Emin) calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
timeFrame: within 24 hours post-dose
measure: 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
timeFrame: within 24 hours post-dose
measure: 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
timeFrame: within 24 hours post-dose
measure: Trough Score (Emin) for Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
timeFrame: within 24 hours post-dose
measure: 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
timeFrame: within 24 hours post-dose
measure: Peak score (Emax) for Alertness/Drowsiness, calculated from scores on a VAS scale of 0-100, where 0=very drowsy and 100=very alert
timeFrame: within 24 hours post-dose
measure: 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
timeFrame: within 24 hours post-dose
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INC Research Toronto, Inc.
state: Ontario
Study officials:
affiliation: INSYS Therapeutics Inc
name: Larry Dillaha, MD
role: STUDY_DIRECTOR
affiliation: INC Research Toronto, Inc.
name: Michael McDonnell, MD
role: PRINCIPAL_INVESTIGATOR
References: