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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
TRIPLE
Enrollment
43
Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.
Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.
Matching placebo provided in capsules or as an oral solution in syringes.
INC Research Toronto, Inc.
Toronto, Ontario, Canada
Peak score (Emax) on Drug Liking calculated from a 100-point visual analogue scale (VAS), where 0=strong disliking and 100=strong liking
Time frame: 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
Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects
Time frame: 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
Time frame: within 24 hours post-dose
Peak score (Emax) for Subjective Drug Value (SDV) in dollars
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 24 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 24 hours post-dose