Drug Abuse, Medication Clinical Trial
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
| Verified date | May 2014 |
| Source | INSYS Therapeutics Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary objective of this study is to evaluate the abuse potential of dronabinol oral solution in recreational cannabinoid users.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Canada | INC Research Toronto, Inc. | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| INSYS Therapeutics Inc |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Peak score (Emax) for Subjective Drug Value (SDV) in dollars | within 24 hours post-dose | No | |
| Secondary | 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 | No |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |