Selective Glucocorticoid Receptor Antagonism in Alcohol Use Disorder: A Human Laboratory Study
Pop Test Oncology LLC
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.
Description
The Investigators will conduct behavioral testing in an individual room with a lounge chair and laptop computer for completing the questionnaires, along with supplies for the bilateral foot CPT. Computerized data collection increases the accuracy of data collection and efficiency of data management. Participants will remain seated in the lounge chair for the duration of the session. Procedures Specific to the Stress-Induction Session Stress-Induction. The stress-induction procedure is the Cold Pressure Test \[CPT\]) stressor. The bilateral foot CPT requires participants to submerge both feet i…
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- No
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 cardi…
Interventions
- Drugalcohol
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.
- BehavioralStress-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.
- DrugPT150
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.
Location
- University of KentuckyLexington, Kentucky