Clinical trial NCT04512365: Reward and Drug Effects on Mood and Brain Response
Official title: Brain-Behavior Markers of Reward and Drug Effects in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis Use
Healthy
Keywords: THC
adult
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Half of the participants will receive placebo during the first laboratory visit and THC during the second laboratory visit. The other half of participants will receive THC during the first laboratory visit and placebo during the second laboratory visit.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.


Eligibility criteria: Inclusion Criteria:

* must be able to give informed consent
* age 18-25 at the time of signing the consent form
* fluency in English
* body mass index of 19-26 (normal/overweight but not obese due to limitations of MRI)
* negative urine drug screen (UDS) for all substances except THC (THC allowed)
* must be medically and neurologically healthy
* 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
* have used cannabis at least 10 times in their life, but report current and past lifetime cannabis use less than 7 days/week (daily)

Exclusion Criteria:

* any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol, interpretation of fMRI data, and/or interfere with study procedures
* current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol/Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide.)
* current Axis-I Diagnostic Statistical Manual-5 diagnosis (although mild and moderate Cannabis Use Disorder (CUD) and mild and moderate Alcohol Use Disorder (AUD) are allowed)
* score \>3 on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for individuals with current AUD
* lifetime other lifetime Substance Use Disorder (although lifetime severe CUD and lifetime severe AUD are allowed)
* currently seeking or engaged in CUD treatment or have desire to cut down or stop cannabis use.
* in recovery or enrolled in treatment for any substance (including cannabis and alcohol)
* lifetime psychosis, mania, Attention-Deficit/Hyperactivity Disorder, Obsessive-Compulsive disorder, Feeding and Eating disorder, or Post-Traumatic Stress Disorder
* score \>7 on the Hamilton Depression Rating Scale or score \>7 on the Hamilton Anxiety Rating Scale
* less than a high school education
* lack of fluency in English
* night shift work
* currently pregnant confirmed by urine pregnancy test or planning pregnancy or lactating (women)
* unwilling/unable to sign informed consent document
* inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report
* left-handed
* presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
* positive UDS for any drug except THC
* positive breathalyzer for acute alcohol intoxication
* heavy alcohol use (\>4 days week) in the past month
* heavy nicotine use (\>20 cigarettes per week) in the past month

Primary outcomes:
measure: Neural reward response- Reward Positivity (RewP) event-related potential
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session RewP to THC session RewP.
measure: Neural reward response- blood-oxygen-level-dependent (BOLD) response
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session BOLD response to THC session BOLD response.
measure: Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Natania A Crane, PhD
role: PRINCIPAL_INVESTIGATOR
References: