Approach-Avoidance and Alcohol Challenge Study in PTSD

NCT06002633 | Recruiting

• 1 other identifier: R01AA030740
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post-Traumatic Stress Disorder; Alcohol Drinking

Outcome Measures

Primary Outcomes (4)

• ratio of approach to avoidance choices

  the number of trials on which individuals chose to avoid vs approach will be quantified during the task and compared between placebo and alcohol conditions

  1 week

• changes in dorsal anterior cingulate cortex activation

  the degree of activation on high conflict trials (relative to low conflict trials) on the task in the dorsal anterior cingulate will be quantified and compared between the placebo and alcohol conditions

  1 week

• Relations between ratio of approach to avoidance choices with alcohol use over a one-year follow-up

  The relationship between the number of trials on which individuals chose to avoid vs approach during the alcohol session with alcohol use over a one-year follow up will be modeled. Number of drinks consumed per day over the course of the follow-up year will be used to calculate Area Under the Curve (AUC), with AUC as the dependent variable.

  1 year

• Relations between changes in dorsal anterior cingulate cortex activation with alcohol use over a one-year follow-up

  The relationship between the degree of activation on high conflict trials (relative to low conflict trials) on the task in the dorsal anterior cingulate during the alcohol session with alcohol use over a one-year follow up will be modeled. Number of drinks consumed per day over the course of the follow-up year will be used to calculate Area Under the Curve (AUC), with AUC as the dependent variable.

  1 year

Study Arms (2)

Alcohol

ACTIVE COMPARATOR

Participants will drink beverages containing alcohol.

Other: Alcohol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Alcohol OTHER

Participants will consume beverages containing alcohol.

Alcohol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• \- Meeting diagnostic criteria for PTSD, confirmed by structured interview

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Elizabeth Lippard, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Josh Cisler, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

5124955198; behavioral.neuroimaging@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: August 21, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We will complete all our analyses and publish results and methodologies in scientific journals before the data are available to the research community. Data will be made available following 6 months after publication.
• Access Criteria: We will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)