Approach-Avoidance and Alcohol Challenge Study in PTSD (PACS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06002633 |
Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : December 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Post-Traumatic Stress Disorder Alcohol Drinking | Other: Alcohol Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Alcohol, Approach-Avoidance, and Neurocircuitry Interactions in PTSD |
Actual Study Start Date : | October 23, 2023 |
Estimated Primary Completion Date : | May 31, 2028 |
Estimated Study Completion Date : | May 31, 2028 |
Arm | Intervention/treatment |
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Active Comparator: Alcohol
Participants will drink beverages containing alcohol.
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Other: Alcohol
Participants will consume beverages containing alcohol. |
Placebo Comparator: Placebo
Participants will drink beverages containing a very low dose of alcohol (placebo condition).
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Other: Placebo
Participants will consume beverages containing a very low dose of alcohol (placebo condition). |
- ratio of approach to avoidance choices [ Time Frame: 1 week ]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
- changes in dorsal anterior cingulate cortex activation [ Time Frame: 1 week ]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
- Relations between ratio of approach to avoidance choices with alcohol use over a one-year follow-up [ Time Frame: 1 year ]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.
- Relations between changes in dorsal anterior cingulate cortex activation with alcohol use over a one-year follow-up [ Time Frame: 1 year ]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.
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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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Inclusion criteria for all participants:
- 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
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Inclusion criteria for PTSD participants:
- Meeting diagnostic criteria for PTSD, confirmed by structured interview
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For all subjects exclusion criteria include:
- 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
- positive pregnancy test
- severe alcohol use disorder
- current severe cannabis use disorder
- any current substance use disorder (other than alcohol, cannabis, or nicotine)
- scores > 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- ever being in an abstinence-oriented treatment program for alcohol use
- reporting wanting to quit drinking but not being able to
- any medical, religious, or other reasons for not drinking alcohol
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- an adverse reaction to alcoholic beverages
- reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
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Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:
- not taking medications for >4 weeks (i.e. participants must be stable on meds)
- acute suicidality with intent
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Additional exclusion criteria for participants in IPV-exposure but no PTSD group:
- history of PTSD
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Additional exclusion criteria for healthy comparison subjects also include:
- any prior psychiatric hospitalizations
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder
- greater than 1 month of lifetime psychotropic medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002633
Contact: Research Coordinator | 5124955198 | behavioral.neuroimaging@austin.utexas.edu |
United States, Texas | |
University of Texas at Austin | Recruiting |
Austin, Texas, United States, 78712 | |
Contact: Research Coordinator 512-495-5198 behavioral.neuroimaging@austin.utexas.edu |
Principal Investigator: | Elizabeth Lippard, PhD | University of Texas at Austin | |
Principal Investigator: | Josh Cisler, PhD | University of Texas at Austin |
Responsible Party: | Elizabeth Thomas Cox Lippard, Assistant Professor, University of Texas at Austin |
ClinicalTrials.gov Identifier: | NCT06002633 |
Other Study ID Numbers: |
R01AA030740 ( U.S. NIH Grant/Contract ) |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | December 22, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After study completion and publication of finding, functional neuroimaging data and behavior data collected following alcohol and placebo conditions will be shared. |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Time Frame: | We will complete all our analyses and publish results and methodologies in scientific journals before the data are available to the research community. Data will be made available following 6 months after publication. |
Access Criteria: | We will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Alcohol Drinking |
Trauma and Stressor Related Disorders Mental Disorders Drinking Behavior |