Recruiting
Phase 1
PT150 Drug for Use in Alcohol Use Disorder
Condition(s) studied
Alcohol Use Disorder
Investigational drug(s) / intervention(s)
alcoholStress-InductionPT150
alcohol: 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: 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: 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 summary
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
Inclusion Criteria:
Meet diagnostic criteria for AUD (moderate or severe) per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5)
Not seeking treatment at the time of the study
English-speaking
Between the ages of 21 and 55 years (individuals under 21 are excluded based on the recommendations of NIAAA that alcohol should not be administered to individuals under the legal drinking age)
Abstinent from alcohol no more than 3 days per week on average
Physically and psychiatrically healthy other than the diagnoses for AUD or tobacco use disorder
ECG, read by cardiologist, within normal limits
Body mass index of 19 - 35
Using an effective form of birth control (e.g., birth control pills, surgical sterilization, condoms, IUD, cervical cap with a spermicide or abstinence) if female
Able to abstain from ALC for 12 hours prior to sessions
No contraindications to ALC or PT150
Exclusion Criteria:
Meet diagnostic criteria for SUDs, save nicotine, other than AUD that in the opinion of a study physician would require medical intervention (e.g., opioid use disorder) or compromise the well-being of the participant
Have abnormal blood chemistry, complete blood count or urinalysis values deemed clinically significant
Have a history of serious physical disease or current physical disease (e.g., impaired cardiovascular functioning, histories of seizure, head trauma or CNS tumors)
Have a current or past history of psychiatric disorder that would interfere with participation (e.g., psychotic \[schizophrenia, schizoaffective\]), bipolar, major depressive disorder)
Have had suicidal ideations in the past 90 days
Pregnant or nursing
Are unwilling/unable to comply with study procedures
Participants scoring \>6 on the Clinical Institute Withdrawal Assessment for Alcohol Revised (CIWA-Ar); the CIWA-Ar will be administered prior to each experimental session participants who score \>6 will be excluded further participation.
Primary outcome measure(s)
- 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| University of Kentucky |
Lexington |
Kentucky |
Recruiting |