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Using Imaging to Assess Effects of THC on Brain Activity (fNIRS)

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ClinicalTrials.gov Identifier: NCT03655717
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

Brief Summary:

To assess effects of THC (n=150) and THC + alcohol (n =50) in MJ users on prefrontal brain activity with functional near infrared spectroscopy (fNIRS) during resting state and during memory task performance.

To do so, 150 participants will complete fNIRS testing 120 minutes following THC or identical placebo at a clinically determined dose of 20-50mg dronabinol (synthetic THC) and 50 participants will complete fNIRS testing following THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol, each at at clinically determined doses designed to produce intoxication.

During peak intoxication in participants determined to be intoxicated, (intoxication defined as self reported intoxication >50 on 100 point VAS, by field sobriety testing by a Drug Recognition Expert, and by clinical evaluation, the fNIRS HbO signal will be significantly greater than at baseline and than at a post-peak assessment, and/or resting state connectivity will increase with THC.


Condition or disease Intervention/treatment Phase
Intoxication Alcohol Intoxication THC Intoxication Combined Alcohol THC Drug: Dronabinol Drug: Ethanol Drug: Placebo Dronabinol Drug: Placebo Ethanol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a double blind, placebo controlled, 2 by 2, crossover study of the effect of intoxication with THC, ethanol, and combined THC and ethanol on brain activity as assessed with fNIRS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects will be randomly assigned to one of the possible orders according to a randomization schedule generated by the study staff using a random number generator and computer program. The MGH research pharmacy will generate a blinded randomization code for order of dosing and will dispense blinded drug in the dose ordered and identical placebo for use on separate study days. Ethanol or placebo drink will be prepared by a member of the research unit staff not otherwise associated with study visits.
Primary Purpose: Diagnostic
Official Title: Using Imaging to Assess Effects of THC on Brain Activity
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : September 17, 2020
Estimated Study Completion Date : December 17, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Placebo Dronabinol + Ethanol
single dose of Placebo Dronabinol + Ethanol See protocol for dosing
Drug: Ethanol
Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
Other Name: oral ethanol

Drug: Placebo Dronabinol
Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)
Other Name: placebo THC capsule

Experimental: Dronabinol + Placebo Ethanol
single dose of Dronabinol + Placebo Ethanol See protocol for dosing
Drug: Dronabinol
THC (dronabinol) at physician determined doses of 10-50mg designed to produce intoxication.
Other Name: oral THC

Drug: Placebo Ethanol
Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.
Other Name: oral placebo ethanol

Experimental: Dronabinol + Ethanol
single dose of Dronabinol + Ethanol See protocol for dosing
Drug: Dronabinol
THC (dronabinol) at physician determined doses of 10-50mg designed to produce intoxication.
Other Name: oral THC

Drug: Ethanol
Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
Other Name: oral ethanol

Placebo Comparator: Placebo Dronabinol + Placebo Ethanol
single dose of Placebo Dronabinol + Placebo Ethanol See protocol for dosing
Drug: Placebo Dronabinol
Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)
Other Name: placebo THC capsule

Drug: Placebo Ethanol
Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.
Other Name: oral placebo ethanol




Primary Outcome Measures :
  1. Change on fNIRS (HbO) measure of prefrontal brain activity and connectivity at rest as an effect of THC intoxication [ Time Frame: effect of study medicine during 6 hour study visit ]
    2 by 2 design

  2. Change on fNIRS (HbO) measure of prefrontal brain activity during memory task as an effect of THC intoxication [ Time Frame: effect of study medicine during 6 hour study visit ]
    2 by 2 design

  3. Change on fNIRS (HbO) measure of prefrontal brain activity and connectivity at rest as an effect of THC + ethanol intoxication [ Time Frame: effect of study medicine during 6 hour study visit ]
    2 by 2 design

  4. Change on fNIRS (HbO) measure of prefrontal brain activity during memory task ) as an effect of THC + ethanol intoxication [ Time Frame: effect of study medicine during 6 hour study visit ]
    2 by 2 design



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weekly or greater Marijuana users
  • Aged 21-55
  • Participants must test positive for cannabis and have no serious unstable medical illness

Exclusion Criteria:

  • Any unstable, serious medical illness, eg. unstable angina, or cardiovascular event in the past 6 months eg. myocardial infarction or stroke.
  • Diabetes, seizure disorder, cirrhosis, schizophrenia, bipolar disorder, clinically significant cardiac conduction disorder, uncontrolled hypertension, tachycardia, renal failure;
  • History of syncope, HIV, Hepatitis C, migraines, head injury with prolonged unconsciousness (> 24 hours);
  • Allergy to sesame oil (contained in Marinol pills) or marinol capsules
  • Current regular use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, other anticholinergic agents;
  • Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)
  • Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.
  • In the opinion of the investigator, not able to safely participate in this study.

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): NCT03655717


Contacts
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Contact: Jodi M Gilman, PhD 617-643-4679 jgilman1@MGH.HARVARD.EDU
Contact: Melissa Maravic, PHD 617-643-1771 MMARAVIC@MGH.HARVARD.EDU

Locations
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United States, Massachusetts
Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry Recruiting
Boston, Massachusetts, United States, 02114
Contact: Melissa C Maravic, PhD, MPH    617-643-1771    melissa.maravic@mgh.harvard.edu   
Principal Investigator: A Eden Evins, MD, MPH         
Principal Investigator: Jodi Gilman, PHD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: A. Eden Evins, MD, MPH Massachusetts General Hospital
Study Director: Jodi M Gilman, PhD Massachusetts General Hospital

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Responsible Party: A. Eden Evins, Director, Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03655717     History of Changes
Other Study ID Numbers: 2015P001516
R42DA043977 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by A. Eden Evins, Massachusetts General Hospital:
fNIRS
THC
Intoxication
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Alcoholic Intoxication
Chemically-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists