Effects of high- vs. low-dose edible THC on alcohol consumption and neural correlates of reward and aversion

Primary Objective

1. Evaluate the effects of consumption of an oral high (20 mg) vs. placebo (0 mg) THC (dronabinol) on brain activation associated with alcohol salience. 2. Test the effects of high THC vs placebo consumption on alcohol self-administration. 3. Test whether neural response under high THC vs placebo predicts differences in alcohol self-administration in the laboratory or alcohol and cannabis co-use in the natural environment.

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Description

Alcohol and cannabis are often used together such that their effects overlap. Such simultaneous use is associated with greater risk for negative consequences, but little is known about the neural mechanisms that underlie simultaneous use. Legal-market cannabis products such as cannabis edibles (which may contain large doses of THC) have not been well-studied in the laboratory, and it is unclear how such products may impact alcohol consumption patterns. The proposed study will explore the effects of orally administered cannabis on neural reward, alcohol self-administration and naturalistic co-use patterns. We propose to test the effects of high-THC (20mg) vs placebo (0mg) dronabinol on alcohol cue-reactivity in 30 adults who drink alcohol and use cannabis. Participants will complete 2 laboratory sessions in this double-blind pharmaco-imaging study with a crossover design. At one session, they will consume a high-dose THC dronabinol before the MRI brain scan and alcohol self-administration session. At the other session, they will undergo the same procedures after consuming the placebo dose. We will also examine if neural responses to THC are associated with real-world co-use patterns as assessed by two weeks of daily-diary collection conducted after participants complete both laboratory sessions.

Details
Age

Adult

Eligibility

For the proposed study, we will recruit 50 individuals (to account for screen failures and withdrawals; goal N for the study is 30 total) aged 21-40. -Included individuals must be at-risk drinkers (reporting at least one binge drinking episode, [defined as at least 5 drinks in one day for males or 4 drinks in one day for females] in the past month), -must report using cannabis at least once in the past month and have experience using high doses (greater than or equal to 20mg) in the past month. -Participants will be required to have a diagnosis of at least mild Cannabis Use Disorder, assessed by the Structured Clinical Interview for DSM-5 (SCID-5) -Have used alcohol and cannabis at the same time in the past month Exclusion criteria include: • a current diagnosis of moderate or severe AUD, • currently seeking treatment for AUD, CUD, or other SUD, • current bipolar or psychotic disorder as assessed by SCID-5; • positive urine drug screen for any illicit substance (other than THC); • positive saliva drug screen for THC, indicating use in the past 1-24 hours; • self-reported liver disease (hepatitis, cirrhosis, hemochromatosis, etc.); • pregnancy, trying to become pregnant, breastfeeding; • MRI contraindications (implanted metal, weight > 315 lb, etc.). • Current use of antibiotics will be exclusionary.

Type of Study

Basic Science

Scope

Local

Locations

Brain Imaging Center (BIC)
Outpatient CTRC

Principal Investigator
Photograph of Joshua Gowin,  PhD

Joshua Gowin, PhD

Study ID

Protocol Number: 22-1314

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