Effects of THC on Alcohol Consumption and Neural Correlates of Reward

NCT ID: NCT06446479

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cannabis Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo first, Dronabinol second

This arm will receive placebo on the first visit, and dronabinol on the second visit

Group Type EXPERIMENTAL

Dronabinol Pill

Intervention Type DRUG

Dronabinol 20 mg

Placebo

Intervention Type DRUG

placebo

Dronabinol first, Placebo second

This arm will receive dronabinol on the first visit, and placebo on the second visit.

Group Type EXPERIMENTAL

Dronabinol Pill

Intervention Type DRUG

Dronabinol 20 mg

Placebo

Intervention Type DRUG

placebo

Interventions

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Dronabinol Pill

Dronabinol 20 mg

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Colorado State University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elnaz Nourollahimoghadam

Role: CONTACT

3037246020

Facility Contacts

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Elnaz Nourollahimoghadam, MD

Role: primary

303-724-6020

Other Identifiers

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22-1314

Identifier Type: -

Identifier Source: org_study_id

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