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The primary objective of this study is to evaluate the abuse potential of dronabinol oral solution in recreational cannabinoid users.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 10 mg | Drug | Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes. |
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| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Dillaha, MD | INSYS Therapeutics Inc | Study Director |
| Michael McDonnell, MD | INC Research Toronto, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INC Research Toronto, Inc. | Toronto | Ontario | M5V 2T3 | Canada |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Dronabinol 30 mg | Drug | Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes. |
|
| Placebo | Drug | Matching placebo provided in capsules or as an oral solution in syringes. |
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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 |