PT150 for Alcohol Use Disorder
This study is investigating if a drug called PT150 can help people with Alcohol Use Disorder (AUD) by reducing the effects of stress and alcohol. Researchers want to see if PT150 can change how your body reacts to stress and alcohol, and how much you desire alcohol. You might be able to join if you are between 21 and 55 years old, speak English, and have been diagnosed with moderate or severe AUD but are not currently seeking treatment. The study aims to enroll 34 participants. Success in this study would mean seeing changes in stress hormones (salivary cortisol) and alcohol demand (how much you want alcohol) after taking PT150.
- Study design
- This is an interventional study with a planned enrollment of 34 participants. The sequence of PT150 doses will be quasi-random.
- What's involved
- You will ingest PT150 (0, 225, or 450 mg) twice daily for five days before experimental sessions. During sessions, you will receive alcohol mixed with soda and undergo a stress-induction procedure where you submerge your feet in ice-cold water for 3 minutes. You will have follow-up visits for up to 34 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed up for up to 34 days after the experimental sessions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PT150 Drug for Use in Alcohol Use Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mark Fillmore, PhD · PRINCIPAL_INVESTIGATOR · Uiversity of Kentucky
Who to contact
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What this trial measures
- Change in salivary cortisol (alcohol)Baseline, week 1, week 2, week 3, and follow up (up to 34 days)
Salivatory samples will be collected before and periodically after the alcohol challenge procedure for 120 minutes using cotton swab salivettes.
- Change in salivary cortisol (stress induction)Baseline, week 1, week 2, week 3, and follow up visit (up to 34 days)
Salivatory samples will be collected before and periodically after the stress induction procedure for 120 minutes using cotton swab salivettes.
- Change in Alcohol Demand (stress induction)Baseline, and sessions 1 - 3 (up to 30 days)
A drug purchasing task will be used to determine how many hypothetical doses of their preferred alcohol beverage participants would purchase across varying prices.
- Change in Alcohol Demand (alcohol)Baseline, and sessions 1 - 3 (up to 30 days)
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.
- Change in Mood (Alcohol)Baseline, and sessions 1 - 3 (up to 30 days)
The short form of the Profile of Mood States. The POMS-SF uses five-point scales (Not at All to Extremely) to measure six aspects of mood (Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment).