Status:
RECRUITING
Approach-Avoidance and Alcohol Challenge Study in PTSD
Lead Sponsor:
University of Texas at Austin
Conditions:
Post-Traumatic Stress Disorder
Alcohol Drinking
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
Individuals with posttraumatic stress disorder (PTSD) have greater prevalence of alcohol use disorders (AUDs), with this comorbidity associated with worse illness outcomes, yet there remains limited m...
Detailed Description
The proposed study will test the conceptual model positing that acute alcohol alters the relative bias in computational mechanisms for threat vs reward, thereby decreasing avoidance to threat and incr...
Eligibility Criteria
Inclusion
- Inclusion criteria for all participants:
- between 21 and 60 years of age
- having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year
- Inclusion criteria for PTSD participants:
- \- Meeting diagnostic criteria for PTSD, confirmed by structured interview
- For all subjects exclusion criteria include:
- history of significant medical illness, particularly if possible changes in cerebral tissue
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale IQ \<85
- contraindication to MRI scanning
- positive pregnancy test
- severe alcohol use disorder
- current severe cannabis use disorder
- any current substance use disorder (other than alcohol, cannabis, or nicotine)
- scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- ever being in an abstinence-oriented treatment program for alcohol use
- reporting wanting to quit drinking but not being able to
- any medical, religious, or other reasons for not drinking alcohol
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- an adverse reaction to alcoholic beverages
- reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
- Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:
- not taking medications for \>4 weeks (i.e. participants must be stable on meds)
- acute suicidality with intent
- Additional exclusion criteria for participants in IPV-exposure but no PTSD group:
- \- history of PTSD
- Additional exclusion criteria for healthy comparison subjects also include:
- any prior psychiatric hospitalizations
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder
- greater than 1 month of lifetime psychotropic medication
Exclusion
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06002633
Start Date
October 23 2023
End Date
May 31 2028
Last Update
April 2 2025
Active Locations (1)
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1
University of Texas at Austin
Austin, Texas, United States, 78712