Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 56 for:    insys

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02094599
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

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

Condition or disease Intervention/treatment Phase
Drug Abuse, Medication Drug: Dronabinol 10 mg Drug: Dronabinol 30 mg Drug: Placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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
Study Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: All Enrolled Participants
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.
Drug: Dronabinol 10 mg
Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.

Drug: Dronabinol 30 mg
Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.

Drug: Placebo
Matching placebo provided in capsules or as an oral solution in syringes.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094599


Locations
Layout table for location information
Canada, Ontario
INC Research Toronto, Inc.
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
Layout table for investigator information
Study Director: Larry Dillaha, MD INSYS Therapeutics Inc
Principal Investigator: Michael McDonnell, MD INC Research Toronto, Inc.

Layout table for additonal information
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02094599     History of Changes
Other Study ID Numbers: INS-13-017
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pharmaceutical Solutions
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists