Approach-Avoidance and Alcohol Challenge Study in PTSD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Texas at Austin

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

For all subjects

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Alcohol

    Other intervention

    Participants will consume beverages containing alcohol.

  • Placebo

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AlcoholActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

ratio of approach to avoidance choices

the number of trials on which individuals chose to avoid vs approach will be quantified during the task and compared between placebo and alcohol conditions

Time frame
1 week
2

changes in dorsal anterior cingulate cortex activation

the degree of activation on high conflict trials (relative to low conflict trials) on the task in the dorsal anterior cingulate will be quantified and compared between the placebo and alcohol conditions

Time frame
1 week
3

Relations between ratio of approach to avoidance choices with alcohol use over a one-year follow-up

The relationship between the number of trials on which individuals chose to avoid vs approach during the alcohol session with alcohol use over a one-year follow up will be modeled. Number of drinks consumed per day over the course of the follow-up year will be used to calculate Area Under the Curve (AUC), with AUC as the dependent variable.

Time frame
1 year
4

Relations between changes in dorsal anterior cingulate cortex activation with alcohol use over a one-year follow-up

The relationship between the degree of activation on high conflict trials (relative to low conflict trials) on the task in the dorsal anterior cingulate during the alcohol session with alcohol use over a one-year follow up will be modeled. Number of drinks consumed per day over the course of the follow-up year will be used to calculate Area Under the Curve (AUC), with AUC as the dependent variable.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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