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Completed

NCT Number: NCT02094599

A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users

The primary objective of this study is to evaluate the abuse potential of dronabinol oral solution in recreational cannabinoid users.

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Key information

Conditions

Drug Abuse, Medication Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

INC Research Toronto, Inc.

Toronto, Ontario, M5V 2T3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol 10 MG

Drug

Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Peak score (Emax) for Drug Effects, calculated from scores on a VAS scale of 0-100, where 0=not at all and 100=extremely

    Time frame: within 24 hours post-dose

    Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects

  2. Peak score (Emax) for a shortened Addiction Research Center Inventory (ARCI) scale of 0-49, where 49 is the highest possible score

    Time frame: within 24 hours post-dose

    Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana

  3. Peak score (Emax) for Subjective Drug Value (SDV) in dollars

    Time frame: within 24 hours post-dose

  4. 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

    Time frame: within 24 hours post-dose

    Categorical measures = Good drug effects, High, Stoned, Bad effects, Any effects

  5. 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

  6. 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

  7. 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

    Time frame: within 24 hours post-dose

    Categorical measures = Euphoria, Dysphoria, Sedation, Marijuana

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

INSYS Therapeutics Inc

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2014
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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