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Cannabinoid
THC for Cannabis Use
Phase < 1
Recruiting
Led By Natania A Crane, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not be taking psychoactive medications that would interfere with dronabinol and/or interpretation of fMRI data, including but not limited to the following classes of psychotropics: antidepressants, anxiolytics, sedative hypnotics, stimulants, antipsychotics, mood stabilizer
negative urine drug screen (UDS) for all substances except THC (THC allowed)
Must not have
Positive UDS for any drug except THC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first and second laboratory visit, at baseline (time 0) and at peak drug response (90-120 minutes) after drug administration. outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during thc
Awards & highlights
All Individual Drugs Already Approved
Summary
This trial will study how THC affects the brain's reward system.
Who is the study for?
This trial is for healthy, English-speaking adults with a BMI of 19-26 who've used cannabis over 10 times but not daily. They must have no severe drug use disorders or need for psychoactive meds, and be free from medical conditions that affect MRI results or are worsened by THC.
What is being tested?
The study examines how THC affects mood and brain responses in non-daily cannabis users compared to a placebo. Participants will undergo fMRI scans to track brain activity changes related to the rewarding effects of THC.
What are the potential side effects?
THC can cause altered mental states, anxiety, changes in mood, sensory perception alterations, increased heart rate, dry mouth, red eyes, coordination issues and memory impairment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not taking any medications that affect mood or the way my brain works.
Select...
My drug test was negative, except for THC.
Select...
My drug test was negative, except for THC.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My drug screen was positive for substances other than marijuana.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first and second laboratory visit, at baseline (time 0) and at peak drug response (90-120 minutes) after drug administration. outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during thc
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first and second laboratory visit, at baseline (time 0) and at peak drug response (90-120 minutes) after drug administration. outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during thc
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neural reward response- Reward Positivity (RewP) event-related potential
Neural reward response- blood-oxygen-level-dependent (BOLD) response
Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: THCExperimental Treatment1 Intervention
Participants will receive THC (7.5 mg) at their first or second laboratory visit.
Group II: Placebo oral capsulePlacebo Group1 Intervention
Participants will receive a placebo at their first or second laboratory visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,039 Total Patients Enrolled
1 Trials studying Cannabis Use
200 Patients Enrolled for Cannabis Use
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,468 Total Patients Enrolled
33 Trials studying Cannabis Use
7,316 Patients Enrolled for Cannabis Use
Natania A Crane, PhDPrincipal Investigator - University of Illinois at Chicago
University of Illinois at Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any medication that affects my mood, brain function, or would interfere with the study drug.I am not taking any medications that affect mood or the way my brain works.My drug screen was positive for substances other than marijuana.You have used cannabis at least 10 times in your life, but you are not a daily user and have not used it in the past week.I feel anxious in small, enclosed spaces.My drug test was negative, except for THC.I am in good physical and neurological health.My drug test was negative, except for THC.I am in good physical and neurological health.
Research Study Groups:
This trial has the following groups:- Group 1: THC
- Group 2: Placebo oral capsule
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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