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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    University of Texas at Austin

    Austin, Texas, United States, 78712

    Approach-Avoidance and Alcohol Challenge Study in PTSD | DecenTrialz