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RECRUITING

NCT06002633

Approach-Avoidance and Alcohol Challenge Study in PTSD

Sponsor: University of Texas at Austin

View on ClinicalTrials.gov

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 mechanistic understanding of how PTSD confers risk for AUD. Understanding risk factors that associate with and predict the development of AUDs in PTSD could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in PTSD aimed at capturing the mechanisms leading to the emergence of AUDs. There is growing evidence PTSD is related to biased decision-making during approach-avoidance conflict. Alcohol is also suggested to alter approach-avoidance decision-making. AUDs and acute alcohol intoxication is associated with a bias to seek out reward despite the possibility of threat (e.g., contributing to relapse following alcohol cue exposure and risky behavior during intoxication respectively). Alcohol-induced changes in approach-avoidance decision-making have not been investigated in the context of PTSD, but emerging data support the investigators' hypothesis that an interaction between alcohol and approach-avoidance conflict in PTSD may occur and contribute to risk for alcohol misuse and development of alcohol problems. No current data, cross-sectional or longitudinal, have tested the role of alcohol-induced changes in approach-avoidance conflict as a mechanism of risk for AUD among individuals with PTSD. To address this gap, the investigators propose to leverage the group's expertise in placebo-controlled alcohol administration procedures, longitudinal modeling, functional neuroimaging, and computational neuroscience approaches to investigate the effects of acute alcohol on approach-avoidance decision-making and mediating changes in multivariate neurocircuitry patterns in limbic, striatal, and salience networks.

Official title: Alcohol, Approach-Avoidance, and Neurocircuitry Interactions in PTSD

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-10-23

Completion Date

2028-05-31

Last Updated

2025-04-02

Healthy Volunteers

Yes

Conditions

Post-Traumatic Stress Disorder Alcohol Drinking

Interventions

OTHER

Alcohol

Participants will consume beverages containing alcohol.

OTHER

Placebo

Participants will consume beverages containing a very low dose of alcohol (placebo condition).

1. 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 2. Inclusion criteria for PTSD participants: \- Meeting diagnostic criteria for PTSD, confirmed by structured interview 3. 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 4. 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 5. Additional exclusion criteria for participants in IPV-exposure but no PTSD group: \- history of PTSD 6. 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

Locations (1)

University of Texas at Austin

Austin, Texas, United States