Developing a Mobile Method to Measure THC-induced Impairment

NCT03804840 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB16-1132a
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.

Conditions

Measuring THC-induced Cognitive Impairment Using a Mobile Application

Outcome Measures

Primary Outcomes (1)

• Simple Reaction Time

  In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.

  Assessed two hour post intervention at peak effects

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

7.5 mg THC

ACTIVE COMPARATOR

Drug: Dronabinol

15 mg THC

ACTIVE COMPARATOR

Drug: Dronabinol

Interventions

Dronabinol DRUG

THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication.

15 mg THC; 7.5 mg THC

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old, males and females (N=44; 36 completers; 18 men, 18 women)
• BMI 19-26
• High school education, fluent in English
• Experienced non-daily marijuana users

You may not qualify if:

• Current drug/alcohol abuse or dependence
• Past year drug/alcohol dependence
• Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
• Past year major depression
• Panic/anxiety attacks in past 2 months
• Post Traumatic Stress Disorder
• Attention Deficit Hyperactivity Disorder
• Cardiovascular illness, high blood pressure, abnormal EKG
• Current medications
• Pregnant or planning to become pregnant

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60615, United States

Location

Related Publications (2)

• Broyd SJ, van Hell HH, Beale C, Yucel M, Solowij N. Acute and Chronic Effects of Cannabinoids on Human Cognition-A Systematic Review. Biol Psychiatry. 2016 Apr 1;79(7):557-67. doi: 10.1016/j.biopsych.2015.12.002. Epub 2015 Dec 8.

  PMID: 26858214 RESULT

• Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem. 2013 Mar;59(3):478-92. doi: 10.1373/clinchem.2012.194381. Epub 2012 Dec 7.

  PMID: 23220273 RESULT

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Elisa Pabon

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: March 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)