Alcohol's Impact on Decision-Making in PTSD
(PACS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byElizabeth Lippard, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas at Austin
Must not be taking: Psychotropics
Disqualifiers: Severe AUD, Severe cannabis use, others
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
15678How 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.
29101112Eligibility 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
+19 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Texas at AustinAustin, TX
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Who Is Running the Clinical Trial?
University of Texas at AustinLead Sponsor
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]Accessible, brief, and self-directed intervention are needed to improve treatment access for individuals with co-occuring PTSD and alcohol misuse. This pilot study tests the feasibility, acceptability, and preliminary efficacy of a brief text message intervention based on cognitive behavioral therapy plus message framing (CBT + Framing) compared to active control providing kind support and attention (KAM), to reduce PTSD symptoms and alcohol use. Two waves of community-based data collection (Wave 1 n = 50; Wave 2 n = 59) were completed. Participants self-reported symptoms at baseline, post-intervention, and 8-week follow-up. Engagement and retention were high, suggesting messages were feasible and acceptable. Across waves and conditions, from baseline to follow-up primary outcomes of PTSD symptoms (medium to large effects), weekly drinks (medium effects), and heavy episodic drinking (small to medium effects) decreased. Consistent with hypotheses, CBT + Framing outperformed KAM for PTSD at post in Wave 2 and for number of heavy drinking episodes at both post and follow-up in Wave 1. Contrary to hypotheses, KAM outperformed CBT + Framing for PTSD at post in Wave 1, and minimal differences were observed between conditions for weekly drinks in both waves. Future studies should continue to develop and test brief, accessible interventions.
Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. [2023]Alcohol use disorder (AUD) is highly prevalent and commonly co-occurs with other psychiatric disorders among Veterans. Provisional evidence supports the use of Approach Avoidance Training (AAT) - a form of computer-delivered cognitive bias modification designed to target implicit approach bias for alcohol-related cues - as an adjunctive program to treat AUD. However, the extent to which AAT is effective for improving AUD recovery outcomes in outpatient Veteran samples and those with psychiatric comorbidities has been understudied to date. Here we describe a double-blind randomized controlled trial of AAT versus a comparison condition (Sham) being conducted in Veterans with comorbid psychiatric conditions completing outpatient standard care.
Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. [2019]The prevalence of alcohol use disorder (e.g., alcohol dependence; AD) among individuals with posttraumatic stress disorder (PTSD) is quite high, with estimates of 52% for men and 30% for women (Kessler, Sonnega, Bromet, Hughes, & Nelson, 1995). There are several interviews and self-report measures of PTSD with good published psychometric properties, and they are routinely used with comorbid AD and PTSD. However, none of these instruments was validated with this population. The current study fills this gap by examining the psychometric properties of the PTSD Symptom Scale-Interview (PSS-I) and the self-report PTSD Diagnostic Scale (PDS) in individuals diagnosed with current PTSD and AD. Both scales comprised of 17 items provide diagnostic and symptom severity information according to DSM-IV-TR criteria. Participants were 167 individuals who were diagnosed with AD and chronic PTSD and were enrolled in a randomized controlled treatment study. Results revealed excellent internal consistency of both the PSS-I and the PDS, good test-retest reliability over a 1-month period, and good convergent validity with the SCID. The specificity of the PSS-I diagnosis of PTSD was better than the PDS diagnosis, the latter exhibiting a greater percentage of false positives. In sum, the results showed that the PSS-I and PDS performed well in this population and can be used with confidence to assess PTSD diagnosis and symptom severity.
Psychosocial functioning in integrated treatment of co-occurring posttraumatic stress disorder and alcohol use disorder. [2022]Co-occurring posttraumatic stress disorder and alcohol use disorder (PTSD/AUD) is associated with poorer psychosocial functioning than either disorder alone; however, it is unclear if psychosocial functioning improves in treatment for PTSD/AUD. This study examined if psychosocial functioning improved in integrated treatments for PTSD/AUD, and if changes in PTSD severity and percentage heavy drinking days (PHDD) during treatment were associated with functioning outcomes. 119 veterans with PTSD/AUD randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure or Seeking Safety completed measures of functioning (Medical Outcomes Survey SF-36), PTSD (Clinician Administered PTSD Scale for DSM-5), and alcohol use (Timeline Follow-Back) at baseline, posttreatment, 3- and 6-month follow-ups. Our findings suggest that psychosocial functioning improved to a statistically significant degree with no significant differences between conditions. Reductions in PTSD severity during treatment were associated with psychosocial functioning improvements, whereas reductions in PHDD were associated with improvement in role impairment at posttreatment. Although psychosocial functioning improves to a statistically significant degree in interventions designed to treat PTSD/AUD, these improvements do not represent clinically meaningful improvements in patients' abilities to navigate important roles. Findings underscore the need to study how to best treat psychosocial functioning impairment in PTSD/AUD.
The impact of screening positive for hazardous alcohol use on the diagnostic accuracy of the PTSD Checklist for DSM-5 among veterans. [2023]The Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a widely used self-report measure of PTSD symptoms that has demonstrated strong psychometric properties across settings and samples. Co-occurring hazardous alcohol use and PTSD are prevalent among veterans, and the effects of alcohol use may impact the performance of the PCL-5. However, this possibility is untested. In this study, we evaluated the PCL-5 diagnostic accuracy for veterans who did and did not screen positive for hazardous alcohol use according to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). Participants were 385 veterans recruited from Veterans Affairs primary care clinics. Results indicated that PCL-5 performance, AUC = .904, 95% CI [.870, .937], did not differ as a product of hazardous alcohol use. PCL-5 diagnostic utility was comparably high for veterans with, AUC = .904; 95% CI [.846, .962], and without, AUC = .904 95% CI [.861, .946], positive AUDIT-C screens. Although optimally efficient cutoff scores for veterans who screened positive were higher (i.e., 34-36) than for those with negative screens (i.e., 30), neither were significantly different from the overall PCL-5 cutoff score (i.e., 32), suggesting that neither veterans with nor without positive AUDIT-C screens require differential PCL-5 cutoff scores. The results do underscore the importance of using PCL-5 cutoff scores in concert with clinical judgment when establishing a provisional PTSD diagnosis and highlight the need for additional study of the impact of comorbidities on PCL-5 diagnostic accuracy and cutoff scores.
Open trial of a personalized feedback intervention and substance-free activity supplement for veterans with PTSD and hazardous drinking. [2023]This study reports findings from an open trial of a two-session intervention for veterans with symptoms of PTSD and hazardous drinking. Rooted in behavioral economic theory, this intervention aimed to decrease alcohol use and increase alcohol-free activities through personalized and normative feedback. This trial assessed the feasibility and acceptability of the intervention in a sample of 15 veterans. Participants completed assessments at baseline and post-intervention (1-month and 3-months). Thirteen participants (86.6%) were retained between the baseline assessment and second intervention session. Acceptability data indicated that veterans overwhelmingly viewed the intervention positively with little dropout between the two sessions. Further, participants in our study reduced alcohol consumption from 37.30 (SD = 17.30) drinks per week at baseline to 22.50 (SD = 27.75) drinks per week at the 1-month assessment and then to 14.60 (SD = 18.64) at the 3-months assessment, representing medium to large effects. PTSD severity also decreased from 57.20 (SD = 16.72) at baseline to 48.90 (SD = 18.99) at the 1-month assessment, representing a small effect. Though effect sizes from pilot trials should be interpreted with caution, findings suggest that this intervention was well-received, feasible to deliver, and may have resulted in improvements in intervention targets.
Reckless Self-Destructive Behavior and PTSD in Veterans: The Mediating Role of New Adverse Events. [2018]The addition of self-destructive and reckless behavior as a symptom of posttraumatic stress disorder (PTSD) in DSM-5 has stimulated renewed interest in understanding relationships between these behaviors and trauma-related psychopathology. This study examined the relationship between reckless and self-destructive behaviors (RSDB), intervening exposure to new adverse events, and later PTSD severity in a sample of trauma-exposed veterans. At baseline, participants were assessed for RSDB (past 5 years) and current PTSD severity (N = 222). PTSD severity was then reassessed approximately 4 years later (N = 148). Overall, RSDB were reported by 74.4% of the sample, with 61.3% engaging in multiple forms of RSDB. The most commonly endorsed behaviors included alcohol/drug abuse (42.8%), driving while intoxicated (29.4%), gambling (24.7%), and aggression (23.1%). There was a positive correlation between RSDB and PTSD severity at both the baseline (r = .16, p = .031) and follow-up assessment (r = .24, p = .005). Path models indicated that exposure to new adverse events fully mediated the effect of Time 1 RSDB on PTSD symptoms at Time 2 (indirect association: β = .05, p = .046). Results suggest that RSDB are common among trauma-exposed veterans and may perpetuate PTSD symptoms by increasing exposure to new adverse events.
PTSD symptom severity and impulsivity among firefighters: Associations with alcohol use. [2020]Firefighters represent a unique population at high risk for trauma exposure, posttraumatic stress disorder (PTSD), and alcohol use. This study explored the main and interactive effects of PTSD symptom severity and impulsivity with regard to alcohol use severity. We hypothesized that higher levels of PTSD symptom severity and impulsivity would be related to greater alcohol use severity. Covariates included trauma load, depressive symptom severity, and romantic relationship status. The sample was comprised of 654 firefighters (Mage = 38.65, SD = 8.60) who endorsed exposure to potentially traumatic events and lifetime alcohol use. Firefighters completed an online questionnaire battery. A series of hierarchical regressions was conducted. PTSD symptom severity and impulsivity were significantly, incrementally associated with alcohol use severity, and a significant interactive effect was documented; firefighters with heightened PTSD symptom severity and impulsivity had the highest levels of alcohol use severity. This line of inquiry has great potential to inform prevention and intervention efforts for this vulnerable population. Clinical and research implications are discussed.
Posttraumatic Stress Disorder and Conduct Problems: The Role of Self-Control Demands. [2022]We tested within- and between-person effects of posttraumatic stress disorder (PTSD) symptoms on conduct problems and alcohol intoxication via self-control demands using multilevel structural equation modeling in a longitudinal burst-design study of 251 U.S. veterans who participated in the recent wars in Iraq and Afghanistan. We theorized that experiencing PTSD symptoms engenders efforts to regulate mood, control thoughts, and inhibit or control behavior that is taxing to the individual (i.e., it places demands on self-control) and hypothesized that this process results in subsequent deficits in regulatory control that manifest in heightened intoxication and conduct problems associated with PTSD. At the within-person level, daytime PTSD symptoms, IRR = 1.09, and self-control demands, IRR = 1.12, exhibited within-person associations with nighttime conduct problems over and above nighttime intoxication. Consistent with our hypothesis, daytime increases in self-control demands mediated the associations between daytime PTSD symptoms and subsequent nighttime conduct problems. The indirect effect between daytime PTSD symptoms and nighttime intoxication via self-control demands was nonsignificant. At the between-person level, self-control demands mediated the associations between PTSD symptoms and conduct problems; however, the expected between-person associations with intoxication were nonsignificant. Drinking behavior is related to but cannot fully account for various difficulties in psychosocial functioning associated with PTSD. The present results suggest that dysregulated behavior may, ironically, stem from individuals' concerted efforts to control and manage overwhelming symptoms. Self-control demands may be a common factor that accounts for a broad range of functional impairments associated with PTSD.
The Role of Impulsivity in the Association Between Posttraumatic Stress Disorder Symptom Severity and Substance Use in Male Military Veterans. [2021]High rates of posttraumatic stress disorder (PTSD) and comorbid substance use disorder (SUD) are prevalent in military veterans. However, few studies have investigated impulsivity as a risk factor for engaging in substance use behavior for individuals who are experiencing PTSD symptoms. The present study evaluated impulsivity as a moderator of the association between PTSD symptoms and alcohol/drug use. Male military veterans (N = 106) completed self-report measures of alcohol use behavior, drug use behavior, and impulsivity. Participants also completed a structured diagnostic interview to assess for PTSD. The findings indicated that impulsivity moderated the relation between total PTSD symptoms and alcohol use, B = 0.01, p = .035, along with associations between alcohol use and two of the symptom clusters: PTSD reexperiencing symptoms, B = 0.01, p = .016; and PTSD avoidance/numbing symptoms, B = 0.01, p = .029. Veterans with high levels of impulsivity were at significantly higher risk of engaging in alcohol use than veterans with low-to-average levels. Impulsivity did not potentiate the relation between PTSD hyperarousal symptoms and alcohol use nor did it moderate the association between any of the PTSD variables and drug use. Impulsivity appears to serve as a significant risk factor for alcohol use, but not drug use, for male veterans experiencing PTSD symptoms. Future studies are necessary to replicate and expand upon these findings, particularly to facilitate the development of integrated evidence-based treatments that target both alcohol use and impulsivity within the context of PTSD.
Working memory and alcohol demand relationships differ according to PTSD symptom severity among veterans with AUD. [2021]Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly comorbid with complex and often unclear associations. Working memory deficits may represent a shared mechanism implicated in emotion regulation and control over impulsive alcohol use. Here we test whether PTSD symptoms and working memory correlated with performance on a behavioral economic assessment of alcohol demand. 113 veterans (mean age 51 years; 89% male) completed an Alcohol Purchase Task (APT) and were assessed for PTSD, alcohol use, and working memory. We examined the interaction of PTSD symptoms and working memory on four indices of alcohol demand measured from the APT; specifically, we used separate models to test whether associations between working memory and intensity (consumption at $0), Omax (maximum expenditure), Pmax (price at maximum expenditure), and elasticity (price sensitivity), differed as a function of PTSD symptoms. In a model controlling for hazardous drinking, average drinking levels, age, sex, marital status, occupation, and education, we observed a significant interaction between PTSD symptoms and working memory on elasticity, whereby greater working memory capacity was associated with greater elasticity for veterans with lower PTSD symptoms. Follow-up analyses regarding specific PTSD symptom domains indicated that this effect was strongest for avoidance symptoms. Taken together, working memory abilities correlated with subjective valuations of alcohol in a laboratory setting for veterans with less severe PTSD symptoms. This work highlights the conditions under which working memory may be a potential target for interventions geared toward reducing alcohol use in veterans with co-occurring PTSD and AUD. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
Sacrificing reward to avoid threat: Characterizing PTSD in the context of a trauma-related approach-avoidance conflict task. [2021]Posttraumatic stress disorder (PTSD) is characterized by heightened avoidance, cognitive inflexibility, and impaired reward processing. Maladaptive behavior in PTSD may reflect an imbalance between approach and avoidance, but no research has investigated approach-avoidance conflict (AAC) in PTSD. The current study investigated approach-avoidance behavior in PTSD using a trauma-related AAC (trAAC) task in two independent samples. In Study 1, 43 women with a current diagnosis of PTSD and 18 healthy comparison subjects were recruited from the community. In Study 2, 53 women with trauma exposure and a range of PTSD symptoms were recruited from a correctional institution. Trials were separated into two phases: conflict (the option most likely to win points was most likely to show a trauma-related image) and congruent (the option most likely to win points was least likely to show a trauma-related image). In Study 1, reward obtainment varied with the task manipulation (i.e., fewer points earned during conflict compared to congruent Phase) in PTSD but not healthy subjects. These results indicate that when avoidance is advantageous (congruent phase), individuals with PTSD show increased task performance, whereas when avoidance is maladaptive (conflict phase), individuals with PTSD show increased sacrifice of reward. In Study 2, higher PTSD symptoms predicted decreased reward earning during the conflict phase, again indicating a sacrifice of reward when avoidance is maladaptive. Across both studies, PTSD associated with increased AAC and sacrifice of reward in the presence of trauma-related stimuli. These studies shed light on AAC in PTSD and could inform more targeted therapy approaches. (PsycInfo Database Record (c) 2020 APA, all rights reserved).