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NCT Number: NCT06446479

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.

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Key information

Conditions

Cannabis Use Disorder

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Elnaz Nourollahimoghadam, MD

CONTACT

[email protected]

303-724-6020

About this study

Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Drink alcohol
  • Use cannabis
  • Contact site for additional details

Exclusion criteria

  • MRI contraindications (implanted metal, weight > 315 lb, etc.).
  • Contact site for additional details

Treatment and study plan

Dronabinol Pill

Drug

Dronabinol 20 mg

Placebo

Drug

placebo

Primary outcomes

  1. Change in alcohol cue-elicited brain activation (fMRI) between medication periods

    Time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.

    Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues

  2. Change in cannabis cue-elicited brain activation (fMRI) between medication periods

    Time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.

    Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues

  3. Alcohol self-administration

    Time frame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.

    Number of drinks self-administered

  4. Self-reported alcoholic drinks consumed

    Time frame: one report per day for the 14 days after the final laboratory visit on day 14.

    # of drinks consumed per day

  5. Self-reported cannabis use

    Time frame: One report per day for the 14 days after the final laboratory visit on day 14

    Amount of cannabis consumed per day

  6. Self-reported cannabis and alcohol co-use

    Time frame: One report per day for the 14 days after the final laboratory visit on day 14.

    Number of days in which cannabis and alcohol were both used

Study contacts

Contact information is provided by the study sponsor or research team.

Elnaz Nourollahimoghadam

CONTACT

[email protected]

3037246020

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado State University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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