Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT06712602
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT06712602
Study Brief:
Protocol Section:
NCT06712602