Understanding how alcohol affects decision-making in people with PTSD

Alcohol, Approach-Avoidance, and Neurocircuitry Interactions in PTSD

This study tests how drinking alcohol affects decision-making in adults with PTSD to see if it helps us understand their relationship with alcohol use and improve treatment options.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: University of Texas at Austin (other)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06002633 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between post-traumatic stress disorder (PTSD) and alcohol use disorders (AUDs), focusing on how acute alcohol exposure influences decision-making related to threat and reward. It aims to identify the neural mechanisms that mediate these changes and predict alcohol use and AUD symptoms over a one-year follow-up. Participants will include adults with PTSD, those exposed to interpersonal violence without PTSD, and healthy controls, all of whom will undergo assessments after consuming alcohol or a placebo. The findings could lead to improved interventions for PTSD and reduce the risk of developing AUDs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 60 who meet the diagnostic criteria for PTSD and have a history of alcohol consumption.

Not a fit: Patients with severe alcohol use disorder or significant medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better treatment strategies for individuals with PTSD, potentially reducing their risk of developing alcohol use disorders.

How similar studies have performed: While there is limited research specifically on the interaction between alcohol and PTSD, similar studies have shown promising results in understanding decision-making processes related to substance use.

Eligibility criteria

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

Where this trial is running

Austin, Texas

• University of Texas at Austin — Austin, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Elizabeth Lippard, PhD — University of Texas at Austin
• Study coordinator: Research Coordinator

Conditions: Post-Traumatic Stress Disorder, Alcohol Drinking