Health TrialsbyHealthPanel

PT150 Drug for Use in Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorPop Test Oncology LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: PT150 with alcohol consumption then stressExperimental treatment 3 interventions
Group B: PT150 with stress then alcohol consumptionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in salivary cortisol (alcohol)

Salivatory samples will be collected before and periodically after the alcohol challenge procedure for 120 minutes using cotton swab salivettes.

Time frame
Baseline, week 1, week 2, week 3, and follow up (up to 34 days)
2

Change in salivary cortisol (stress induction)

Salivatory samples will be collected before and periodically after the stress induction procedure for 120 minutes using cotton swab salivettes.

Time frame
Baseline, week 1, week 2, week 3, and follow up visit (up to 34 days)
3

Change in Alcohol Demand (stress induction)

A drug purchasing task will be used to determine how many hypothetical doses of their preferred alcohol beverage participants would purchase across varying prices.

Time frame
Baseline, and sessions 1 - 3 (up to 30 days)
4

Change in Alcohol Demand (alcohol)

A drug purchasing task will be used to determine how many hypothetical doses of the alcoholic beverage given during the session participants would purchase across varying prices.

Time frame
Baseline, and sessions 1 - 3 (up to 30 days)

Secondary outcomes

1

Change in Heart Rate (Stress)

Time frame
Baseline, sessions 1 - 3, and follow up visit (up to 34 days)
2

Change in Heart Rate (Alcohol)

Time frame
Baseline, sessions 1 - 3, and follow up visit (up to 34 days)
3

Change in blood pressure (stress)

Time frame
Baseline, sessions 1 - 3, and follow up visit (up to 34 days)
4

Change in blood pressure (alcohol)

Time frame
Baseline, sessions 1 - 3, and follow up visit (up to 34 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pop Test Oncology LLC

Lead sponsor

University of Kentucky

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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