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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how alcohol affects decision-making in people with PTSD, particularly when they face choices involving potential risks and rewards. Researchers aim to determine if PTSD increases the risk of developing alcohol use disorders due to altered decision-making. Participants will consume either alcohol or a placebo (a non-alcoholic version) to examine these effects. The trial seeks individuals aged 21-60 who have PTSD and have consumed at least a few drinks on two occasions in the past year. As an unphased trial, this study offers a unique opportunity to enhance understanding of PTSD and alcohol use, potentially benefiting future treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many people with PTSD often drink alcohol. One study found a close link between PTSD symptoms and increased alcohol use. Another study suggested that treating PTSD and alcohol use disorder together can significantly reduce PTSD symptoms. This indicates that people with PTSD might drink to cope, leading to harmful drinking habits.

Regarding safety, studies on alcohol use in PTSD patients regularly monitor participants' alcohol consumption and its effects on thinking and coordination. Although these studies do not focus specifically on safety, they show that researchers closely monitor alcohol use.

Overall, there is a known connection between PTSD and alcohol use, but detailed safety information on alcohol's effects in these studies remains limited. Participants should consider this when deciding whether to join a trial involving alcohol consumption. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how alcohol affects decision-making in individuals with PTSD, which is a new angle compared to traditional treatments like therapy or medication that focus on reducing symptoms. This study uses an innovative approach by incorporating an "approach-avoidance" technique alongside an alcohol challenge, allowing researchers to observe changes in decision-making behavior in real-time. The trial aims to uncover how alcohol influences cognitive processes in PTSD, potentially leading to more targeted strategies that address decision-making impairments, which are not directly tackled by current standard treatments.

What evidence suggests that this trial's treatments could be effective for PTSD and alcohol use disorders?

This trial will compare the effects of alcohol and a placebo on decision-making in individuals with PTSD. Research has shown that people with PTSD often struggle more with alcohol use than those without PTSD. Alcohol can influence decision-making in people with PTSD, particularly in challenging situations where they must choose between a possible reward and a potential threat. This can lead to risky behaviors, such as drinking more despite knowing the harm. Some studies suggest that treating PTSD and alcohol problems together can reduce PTSD symptoms and assist with drinking issues. However, no single treatment works best for both conditions. Understanding how alcohol impacts decision-making in PTSD might aid in developing better treatment strategies. ^{2 3 6 7 8}

Who Is on the Research Team?

Elizabeth Lippard, PhD

Principal Investigator

University of Texas at Austin

Josh Cisler, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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 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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6561398/

The Epidemiology of Post-Traumatic Stress Disorder and ... Research has shown that individuals with post-traumatic stress disorder (PTSD) use alcohol and experience alcohol use disorder (AUD) to a greater degree than ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836411

Concurrent Treatment of PTSD and Alcohol Use Disorder ... This trial indicates that integrated treatment for comorbid PTSD and SUD significantly reduces PTSD symptom severity in women with PTSD and AUD ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5375032/

PTSD and Alcohol Use Disorder: A Critical Review of ... All but one of the studies found that PTSD symptoms and drinking outcomes improved significantly over time. There is not one agent with clear evidence of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460321000216

Effect of trauma-related stress after alcohol consumption on ... Trauma-related stress increased willingness to drive after alcohol consumption. Trauma-related stress lessened perceived likelihood of getting in an accident.

5. med.nyu.edu med.nyu.edu/departments-institutes/psychiatry/research/alcohol-use-disorder-traumatic-stress

Alcohol Use Disorder & Traumatic Stress Research The symptoms of PTSD interact with those of alcohol use disorder in a self-exacerbating cycle. Our researchers study treatments that may address both conditions ...

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Post-traumatic stress and future substance use outcomes Conclusion. PTSD symptoms were highly associated with tobacco and alcohol use, while the association with prospective cannabis use is not clear.

7. tsaco.bmj.com tsaco.bmj.com/content/7/1/e000913

Post-traumatic stress disorder (PTSD) symptoms and ... Approximately one-quarter of patients had one or more positive indicators for stimulant use, and approximately 10% of patients had a positive ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9233097/

Posttraumatic stress disorder, drinking to cope, and harmful ... Findings suggest that coping-related drinking is a strong mediator in the relation between PTSD and harmful alcohol use.