200 Participants Needed

Alcohol's Impact on Decision-Making in PTSD

(PACS Trial)

RC
Overseen ByResearch Coordinator
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have been taking their medications for more than 4 weeks, meaning you must be stable on your current medications to participate.

What data supports the effectiveness of the treatment Approach-Avoidance and Alcohol Challenge Study, Minipress for PTSD and alcohol use?

The Approach Avoidance Training (AAT) has shown provisional evidence as a helpful addition to treat alcohol use disorder, especially in veterans with other mental health conditions. Additionally, integrated treatments for PTSD and alcohol use disorder have been associated with improvements in psychosocial functioning, suggesting potential benefits for combined approaches.12345

Is the treatment for alcohol's impact on decision-making in PTSD safe for humans?

The studies reviewed do not provide specific safety data for the treatment of alcohol's impact on decision-making in PTSD, but they do suggest that interventions for alcohol misuse and PTSD, such as text message interventions and personalized feedback, are generally well-received and feasible, with participants showing reduced alcohol consumption and PTSD symptoms.15678

How does this treatment differ from other treatments for PTSD?

The treatment in this trial is unique because it focuses on understanding how alcohol affects decision-making in individuals with PTSD, particularly by examining impulsivity and working memory as factors influencing alcohol use. This approach is different from standard treatments as it aims to integrate evidence-based strategies that target both alcohol use and impulsivity within the context of PTSD.29101112

What is the purpose of this trial?

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.

Research Team

EL

Elizabeth Lippard, PhD

Principal Investigator

University of Texas at Austin

JC

Josh Cisler, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

This trial is for adults aged 21-60 with PTSD who have had at least two occasions in the past year where they consumed a significant amount of alcohol (4 drinks for men, 3 for women). They must be diagnosed with PTSD through an interview.

Inclusion Criteria

Participants must have consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year
PTSD participants must meet diagnostic criteria for PTSD, confirmed by structured interview
I am between 21 and 60 years old.

Exclusion Criteria

Full Scale IQ <85
I have a serious medical condition that could affect my brain.
Contraindication to MRI scanning
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo placebo-controlled alcohol administration procedures to investigate the effects of acute alcohol on approach-avoidance decision-making

1 week
Multiple sessions for alcohol and placebo administration

Follow-up

Participants are monitored for changes in alcohol use and symptoms of AUDs over a one-year period

1 year

Treatment Details

Interventions

  • Approach-Avoidance and Alcohol Challenge Study
Trial Overview The study examines how acute alcohol consumption affects decision-making related to approach-avoidance conflict in individuals with PTSD. It involves controlled administration of alcohol and placebo, along with neuroimaging and computational analysis.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: AlcoholActive Control1 Intervention
Participants will drink beverages containing alcohol.
Group II: PlaceboPlacebo Group1 Intervention
Participants will drink beverages containing a very low dose of alcohol (placebo condition).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Findings from Research

A pilot study involving 109 participants tested a brief text message intervention based on cognitive behavioral therapy (CBT) and message framing, showing high feasibility and acceptability for individuals with co-occurring PTSD and alcohol misuse.
The CBT + Framing intervention demonstrated significant reductions in PTSD symptoms and heavy drinking episodes compared to a supportive control group, although results varied across different waves of the study, indicating the need for further research on effective interventions.
A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample.Bedard-Gilligan, MA., Dworkin, ER., Kaysen, D., et al.[2022]
This study is the first randomized controlled trial assessing the effectiveness of Approach Avoidance Training (AAT) as an adjunctive treatment for Alcohol Use Disorder (AUD) in Veterans with comorbid psychiatric conditions, involving 136 participants over 6 weeks.
If successful, AAT could provide a low-cost and effective treatment option for improving recovery outcomes in Veterans with AUD, as it specifically targets implicit biases towards alcohol-related cues.
Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial.Caudle, MM., Klaming, R., Fong, C., et al.[2023]
The PTSD Symptom Scale-Interview (PSS-I) and the PTSD Diagnostic Scale (PDS) were found to have excellent reliability and validity for diagnosing PTSD in individuals with alcohol use disorder, based on a study of 167 participants.
The PSS-I demonstrated better specificity in diagnosing PTSD compared to the PDS, which had a higher rate of false positives, making the PSS-I a more reliable tool for assessment in this population.
Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence.Powers, MB., Gillihan, SJ., Rosenfield, D., et al.[2019]

References

A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. [2022]
Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. [2023]
Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. [2019]
Psychosocial functioning in integrated treatment of co-occurring posttraumatic stress disorder and alcohol use disorder. [2022]
The impact of screening positive for hazardous alcohol use on the diagnostic accuracy of the PTSD Checklist for DSM-5 among veterans. [2023]
Open trial of a personalized feedback intervention and substance-free activity supplement for veterans with PTSD and hazardous drinking. [2023]
Reckless Self-Destructive Behavior and PTSD in Veterans: The Mediating Role of New Adverse Events. [2018]
PTSD symptom severity and impulsivity among firefighters: Associations with alcohol use. [2020]
Posttraumatic Stress Disorder and Conduct Problems: The Role of Self-Control Demands. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The Role of Impulsivity in the Association Between Posttraumatic Stress Disorder Symptom Severity and Substance Use in Male Military Veterans. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Working memory and alcohol demand relationships differ according to PTSD symptom severity among veterans with AUD. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Sacrificing reward to avoid threat: Characterizing PTSD in the context of a trauma-related approach-avoidance conflict task. [2021]
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