Drug Abuse, Medication
Conditions
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.
Interventions
DRUGDronabinol 10 mg
Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.
DRUGDronabinol 30 mg
Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.
DRUGPlacebo
Matching placebo provided in capsules or as an oral solution in syringes.
Sponsors
INSYS Therapeutics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana |
| 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 | Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects |
| 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 | — |
| 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 | Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects |
| 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 | — |
| 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 | within 24 hours post-dose | Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana |
Countries
Canada
Outcome results
None listed