Alcohol's Impact on Decision-Making in PTSD

(PACS Trial)

Overseen By Research Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Psychotropics

Disqualifiers: Severe AUD, Severe cannabis use, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{2 9 10 11 12}

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

Elizabeth Lippard, PhD

Principal Investigator

University of Texas at Austin

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

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

Group I: Alcohol Active Control 1 Intervention

Participants will drink beverages containing alcohol.

Group II: Placebo Placebo Group 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 119 veterans with co-occurring PTSD and alcohol use disorder, integrated treatments led to statistically significant improvements in psychosocial functioning, but these improvements were not clinically meaningful for daily life roles.

Reductions in PTSD severity were linked to better psychosocial functioning, while decreases in heavy drinking days were associated with less role impairment, highlighting the complex relationship between PTSD, alcohol use, and functioning outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial functioning in integrated treatment of co-occurring posttraumatic stress disorder and alcohol use disorder. Lyons, R., Panza, KE., Helm, J., et al.[2022]

The PTSD Checklist for DSM-5 (PCL-5) is effective for diagnosing PTSD in veterans, showing high diagnostic accuracy (AUC = .904) regardless of whether they have hazardous alcohol use, as assessed by the AUDIT-C.

While the optimal cutoff scores for PTSD diagnosis were slightly higher for veterans with hazardous alcohol use, the overall PCL-5 cutoff score remains applicable for both groups, emphasizing the need for clinical judgment alongside the PCL-5 results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of screening positive for hazardous alcohol use on the diagnostic accuracy of the PTSD Checklist for DSM-5 among veterans. Sistad, RE., Kimerling, R., Schnurr, PP., et al.[2023]

The two-session intervention for veterans with PTSD and hazardous drinking was well-received and feasible, with 86.6% of participants completing the program without dropping out.

Participants significantly reduced their alcohol consumption from an average of 37.30 drinks per week at baseline to 14.60 drinks per week by the 3-month assessment, alongside a small decrease in PTSD severity, indicating potential effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open trial of a personalized feedback intervention and substance-free activity supplement for veterans with PTSD and hazardous drinking. Luciano, MT., McDevitt-Murphy, ME., Murphy, JG., et al.[2023]

In a study of 222 trauma-exposed veterans, 74.4% reported engaging in reckless and self-destructive behaviors (RSDB), which were linked to higher PTSD severity both at the start and after approximately 4 years.

The study found that new adverse events fully mediated the relationship between initial RSDB and later PTSD symptoms, suggesting that these behaviors may worsen PTSD by leading to further trauma exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reckless Self-Destructive Behavior and PTSD in Veterans: The Mediating Role of New Adverse Events. Lusk, JD., Sadeh, N., Wolf, EJ., et al.[2018]

In a study of 654 firefighters, higher levels of PTSD symptom severity and impulsivity were found to be significantly associated with increased alcohol use severity, highlighting a concerning link between mental health and substance use in this population.

The research indicates that firefighters with both high PTSD symptoms and impulsivity are at the greatest risk for severe alcohol use, suggesting that targeted prevention and intervention strategies could be beneficial for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD symptom severity and impulsivity among firefighters: Associations with alcohol use. Bartlett, BA., Smith, LJ., Lebeaut, A., et al.[2020]

In a study of 251 U.S. veterans, PTSD symptoms were linked to increased self-control demands, which in turn were associated with heightened conduct problems at night, indicating that efforts to manage PTSD symptoms can lead to behavioral issues.

While PTSD symptoms and self-control demands were related to conduct problems, they did not significantly correlate with alcohol intoxication, suggesting that drinking behavior alone does not explain the broader psychosocial challenges faced by individuals with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress Disorder and Conduct Problems: The Role of Self-Control Demands. Simons, RM., Walters, KJ., Keith, JA., et al.[2022]

In a study of 106 male military veterans, impulsivity was found to significantly increase the risk of alcohol use among those experiencing PTSD symptoms, particularly related to reexperiencing and avoidance/numbing symptoms.

However, impulsivity did not affect the relationship between PTSD hyperarousal symptoms and alcohol use, nor did it influence drug use, suggesting that targeting impulsivity may be crucial for developing effective treatments for alcohol use in veterans with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Impulsivity in the Association Between Posttraumatic Stress Disorder Symptom Severity and Substance Use in Male Military Veterans. Mahoney, CT., Cole, HE., Gilbar, O., et al.[2021]

In a study of 113 veterans, working memory capacity was found to influence how PTSD symptoms affected their sensitivity to alcohol prices, suggesting that better working memory may help veterans with lower PTSD symptoms make more controlled decisions about alcohol use.

The strongest effects were seen in veterans with avoidance symptoms of PTSD, indicating that targeting working memory could be a promising strategy for interventions aimed at reducing alcohol use in those with both PTSD and alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working memory and alcohol demand relationships differ according to PTSD symptom severity among veterans with AUD. Abram, SV., Batki, SL., Pennington, DL.[2021]

In two studies involving a total of 96 women, those with PTSD demonstrated a significant approach-avoidance conflict, sacrificing potential rewards when faced with trauma-related stimuli, indicating a maladaptive response to avoidance.

The findings suggest that individuals with PTSD perform better when avoidance is beneficial but struggle to earn rewards when avoidance is detrimental, highlighting the need for targeted therapeutic strategies to address these behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacrificing reward to avoid threat: Characterizing PTSD in the context of a trauma-related approach-avoidance conflict task. Weaver, SS., Kroska, EB., Ross, MC., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Psychosocial functioning in integrated treatment of co-occurring posttraumatic stress disorder and alcohol use disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of screening positive for hazardous alcohol use on the diagnostic accuracy of the PTSD Checklist for DSM-5 among veterans. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Open trial of a personalized feedback intervention and substance-free activity supplement for veterans with PTSD and hazardous drinking. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Reckless Self-Destructive Behavior and PTSD in Veterans: The Mediating Role of New Adverse Events. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

PTSD symptom severity and impulsivity among firefighters: Associations with alcohol use. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress Disorder and Conduct Problems: The Role of Self-Control Demands. [2022]

10. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Working memory and alcohol demand relationships differ according to PTSD symptom severity among veterans with AUD. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Sacrificing reward to avoid threat: Characterizing PTSD in the context of a trauma-related approach-avoidance conflict task. [2021]