Alcohol Use DisorderNCT05786157
Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship
A study testing Alcohol Administration in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder, Posttraumatic Stress Disorder, Couples
- What is being tested?
- Alcohol Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender identity; any race or ethnicity; ages 21 years or older.
- Must report ≥ 2 heavy drinking episodes in the past 30 days (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) and consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory (assessed via the TLFB).
- At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the CTS-2).
- Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.
- One or both partners in half the couples will be required to meet diagnostic criteria for PTSD or subthreshold PTSD (assessed by the CAPS-5).
Who cannot join
- Possible drug use disorder (except caffeine or nicotine) as meeting DSM-5 diagnostic criteria via the QuickSCID; Recent recreational drug use (e.g., cannabis) is acceptable.
- Severe alcohol use disorder as meeting DSM-5 diagnostic criteria via the QuickSCID. Applies to those receiving alcohol administration only.
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- Current suicidal or homicidal ideation and intent.
- History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.
- Body weight > 250 lbs (in order to rigorously control alcohol dosing). Applies to those receiving alcohol administration only.
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- Use of medications such as lithium, methadone, alpha or beta blockers or cholinergic/ anticholinergic drugs likely to confound normative cardiovascular responding for the psychophysiological component of the project. Applies to those receiving alcohol administration only.
- Pregnancy or breastfeeding.
- Severe or unilateral partner violence in the past 6 months as measured by the CTS-2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julianne Flanagan contact
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Stacey Sellers, 8437925807, sellersst@musc.edu
Julianne Flanagan, PhD
About this study
Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.
This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA).
Read the detailed description
Alcohol misuse has a salient precipitous effect on intimate partner violence (IPV), which is a persistent public health crisis affecting approximately one-third of the U.S. population. Posttraumatic stress disorder (PTSD) is highly prevalent, has a clear causal effect on alcohol misuse, and it is a robust independent predictor of IPV. However, few studies have examined the combined effects of PTSD and alcohol misuse on IPV. This question is critical to address because effective prevention and treatment approaches for alcohol-related IPV are scant. Integrating these two siloed areas of the literature can help inform the development of novel, trauma-informed modalities for couples to produce stronger and more sustainable outcomes. Dr. Flanagan is the ideal candidate to advance the clinical science in this area. Under the proposed mid-career development award, she will accelerate her thriving patient-oriented alcohol research program by enhancing her skills with 1) oral alcohol administration, 2) intensive ambulatory assessment, and 3) psychophysiology. She will achieve these goals through expert consultation, didactic training, and implementation of the proposed research project. Her team will examine the combined effects of alcohol misuse and PTSD on alcohol-related IPV among couples (N=70) in both a controlled laboratory setting and in naturalistic settings. The study, which was designed to complement mentees' independent research interests, will also compare outcomes across settings and explore heart rate variability as a physiological mechanism underlying the hypothesized relations. The invaluable protected time and resources provided by this K24 will enable Dr. Flanagan to achieve her primary goal of expanding her mentoring availability and skillset at this pivotal mid-career stage. She will engage a program of didactics and expert coaching to amplify her investment in diversity, equity, and inclusion in mentoring, leadership, and science. Achieving these synergistic objectives will accelerate the science of couple and family alcohol research and set the stage for innovative new dyadic treatments. This award will also ensure that Dr. Flanagan is equipped to support the next generation of enthusiastic new investigators and to ensure the longevity of this vital yet underrepresented area of the alcohol field.
- Conditions
- Alcohol Use Disorder, Posttraumatic Stress Disorder, Couples
- Being tested
- Alcohol Administration
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol AdministrationOther
Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
| Study group | Role | What they receive |
|---|---|---|
| alcohol administration paradigm | Experimental | Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC) Receives: Other: Alcohol Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory intimate partner aggression
Taylor aggression paradigm
Measured: 2 hours
Naturalistic intimate partner aggression
self-report using ecological momentary assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julianne Flanagan, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786157
- Sponsor's protocol ID
- Pro00127577
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Couple and Family Alcohol Treatment Through Patient-Oriented Research and Mentorship
- ClinicalTrials.gov ID
- NCT05786157
- Acronym / sponsor ID
- Pro00127577
- Conditions
- Alcohol Use Disorder, Posttraumatic Stress Disorder, Couples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.
This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA).
Detailed description
Alcohol misuse has a salient precipitous effect on intimate partner violence (IPV), which is a persistent public health crisis affecting approximately one-third of the U.S. population. Posttraumatic stress disorder (PTSD) is highly prevalent, has a clear causal effect on alcohol misuse, and it is a robust independent predictor of IPV. However, few studies have examined the combined effects of PTSD and alcohol misuse on IPV. This question is critical to address because effective prevention and treatment approaches for alcohol-related IPV are scant. Integrating these two siloed areas of the literature can help inform the development of novel, trauma-informed modalities for couples to produce stronger and more sustainable outcomes. Dr. Flanagan is the ideal candidate to advance the clinical science in this area. Under the proposed mid-career development award, she will accelerate her thriving patient-oriented alcohol research program by enhancing her skills with 1) oral alcohol administration, 2) intensive ambulatory assessment, and 3) psychophysiology. She will achieve these goals through expert consultation, didactic training, and implementation of the proposed research project. Her team will examine the combined effects of alcohol misuse and PTSD on alcohol-related IPV among couples (N=70) in both a controlled laboratory setting and in naturalistic settings. The study, which was designed to complement mentees' independent research interests, will also compare outcomes across settings and explore heart rate variability as a physiological mechanism underlying the hypothesized relations. The invaluable protected time and resources provided by this K24 will enable Dr. Flanagan to achieve her primary goal of expanding her mentoring availability and skillset at this pivotal mid-career stage. She will engage a program of didactics and expert coaching to amplify her investment in diversity, equity, and inclusion in mentoring, leadership, and science. Achieving these synergistic objectives will accelerate the science of couple and family alcohol research and set the stage for innovative new dyadic treatments. This award will also ensure that Dr. Flanagan is equipped to support the next generation of enthusiastic new investigators and to ensure the longevity of this vital yet underrepresented area of the alcohol field.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)
| Arm | Type | Receives |
|---|---|---|
| alcohol administration paradigm | Experimental | Other: Alcohol AdministrationParticipants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any gender identity; any race or ethnicity; ages 21 years or older.
- Must report ≥ 2 heavy drinking episodes in the past 30 days (i.e., 4 or more drinks for women, 5 or more for men in ≤ 2 hours) and consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory (assessed via the TLFB).
- At least one instance of physical IPV in the current relationship reported by at least one partner within the couple (assessed by the CTS-2).
- Participants must agree not to drive or operate machinery for the remainder of the experimental visit day. Transportation will be provided if necessary.
- One or both partners in half the couples will be required to meet diagnostic criteria for PTSD or subthreshold PTSD (assessed by the CAPS-5).
Key exclusion criteria (9 listed)
- Possible drug use disorder (except caffeine or nicotine) as meeting DSM-5 diagnostic criteria via the QuickSCID; Recent recreational drug use (e.g., cannabis) is acceptable.
- Severe alcohol use disorder as meeting DSM-5 diagnostic criteria via the QuickSCID. Applies to those receiving alcohol administration only.
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- Current suicidal or homicidal ideation and intent.
- History of or current psychiatric or medical condition for which alcohol administration is medically contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol AdministrationParticipants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC) | Other | alcohol administration paradigm |
Primary outcome
Laboratory intimate partner aggression
Time frame: 2 hours
Taylor aggression paradigm
Naturalistic intimate partner aggression
Time frame: 28 days
self-report using ecological momentary assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julianne Flanagan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Administration in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Sellers (843-792-5807, sellersst@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory intimate partner aggression (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.