PT150 Drug for Use in Alcohol Use Disorder

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Pop Test Oncology LLC
Study ID
NCT06712602
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • alcohol — DRUG
    During the alcohol administration session participants will receive a single administration of alcohol (0.5 g/kg) mixed with lemon lime soda. Participants will consume the drink within 5 min.
  • Stress-Induction — BEHAVIORAL
    The stress-induction procedure is the Cold Pressure Test \[CPT\]) stressor. The bilateral foot CPT requires participants to submerge both feet in ice-cold water (24°C) for 3 minutes.
  • PT150 — DRUG
    Participants will ingest PT150 (0, 225, 450 mg) twice daily (e.g., 0800, 2000h) for 5 five days prior to the conduct of the experimental sessions. The sequence of PT150 doses will be quasi-random such that participants will be maintained on the lower dose of PT150 (i.e., 225 mg twice/day) before the higher dose.

Study Details

The goal of this study is to learn if PT150 can reduce the behavioral and physical effects of stress, alcohol, and alcohol use in people with alcohol use disorder.

Key Dates

Start date
Feb 1, 2025
Status verified
May 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: PT150 with alcohol consumption then stress
    Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental alcohol administration session. No less than 24 hours later, participants will then complete an experimental stress induction session.
  • Experimental: PT150 with stress then alcohol consumption
    Following at least five days of maintenance on a randomized dose of PT150, participants will complete an experimental session involving stress induction. No less than 24 hours later, participants will then complete an experimental alcohol administration session.

Primary Outcome Measure

Change in salivary cortisol (alcohol) [ Time Frame: Baseline, week 1, week 2, week 3, and follow up (up to 34 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Kelsey Padgett
[email protected]
859-257-5794
Mark Fillmore, PhD
[email protected]
859-351-9109
Mark Fillmore, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Kentucky· Lexington, KY

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