Alcohol MisuseNCT07414589
Brief Alcohol Treatment for Women Veterans in Primary Care
A study testing Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care in people with Alcohol Misuse, run by Syracuse VA Medical Center at 1 site in United States.
Trial summary
The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2030
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status
- past-year Syracuse VAMC or community-based outpatient clinic (CBOC) primary care appointment
- identify as woman OR use women's PC services
- unhealthy alcohol use (AUDIT ≥ 7)
Who cannot join
- current substance use treatment outside PC
- current psychosis, mania, or dementia (>10 on the BOMC)
- need for a higher level of alcohol or substance use care (detoxification, residential treatment) as indicated by a) patient preference b) withdrawal symptoms that indicate a need to monitor (≥23 on the AWSC) or high risk substance use (≥27 on the ASSIST)
- imminent risk of suicide.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Syracuse VA Medical Center
Syracuse, New York, 13210
Katherine A Buckheit, PhD, 315-425-4400 ext. 56742, katherine.buckheit@va.gov
Katherine A Buckheit, PhD
About this study
Official title: A Brief, Integrated Intervention for Women Veterans With Unhealthy Alcohol Use in Primary Care
The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. The main questions it aims to answer are:
- Is the treatment feasible and acceptable to women Veteran primary care patients?
- Can the treatment help reduce alcohol use, alcohol-related problems, and improve quality of life? Researchers will compare the new treatment to usual treatment that primary care patients would normally receive. Participants will be asked to participate in either the new behavioral treatment or usual primary care treatment and attend 3 appointments to answer questions about their alcohol use, quality of life, other mental health symptoms, and what they thought of their behavioral treatment.
- Conditions
- Alcohol Misuse
- Being tested
- Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care, Primary care usual care
- Keywords
- alcohol, integrated primary care, women Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary CareBehavioural
The intervention consists of 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. It includes 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use that have been adapted from existing evidence-based treatments in integrated primary care and specialty care. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns, including mood, trauma, sleep, and pain.
Primary care usual careBehavioural
Primary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention for unhealthy alcohol use | Experimental | Participants in this arm will attend 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. All participants will attend 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns. Receives: Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care |
| Usual Care | Active comparator | Primary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment Receives: Behavioral: Primary care usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported quality of life from baseline to 6-months post-treatment
Quality of life will be assessed by the abbreviated World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report measure of QoL in the past 2 weeks in 4 areas (social, physical, psychological, and environment) on a 1-5 scale.
Measured: From baseline to 6 months post-treatment
Change in self-reported alcohol-related problems from baseline to 6 months post-treatment
Alcohol problems will be assessed by the Short Inventory of Problems-Revised (SIP-R)147, a 17-item self-report measure of frequency of alcohol problems on a 0-3 scale.
Measured: From baseline to 6 months post-treatment
Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment
Alcohol-specific functional impairment will be assessed by the Addiction Severity Index - Lite, a semi-structured interview developed among Veterans in substance use treatment that assesses alcohol and drug use and problems and 5 areas of functioning: medical, legal, psychiatric, employment, and family/social
Measured: Baseline to 6 months post-treatment
Feasibility - average session length
Length of sessions in the experimental condition will be measured to test if the average is within guidelines for integrated primary care treatment (30 minutes maximum).
Measured: For the duration of the intervention period, 8-12 weeks post-baseline.
Intervention fidelity
An independent rater will listen to session tapes and record if each essential element was delivered on a checklist.
Measured: For the duration of the intervention period, 8-12 weeks post-baseline.
Self-reported patient acceptability of the experimental intervention
Patient acceptability will be assessed with the Client Satisfaction Questionnaire (CSQ), an 8-item self-report measure. Acceptability ratings of at least "moderate" on the majority (5/8) of items on the CSQ will be considered acceptable.
Measured: After completing the behavioral health treatment, 8-12 weeks post-baseline.
Secondary outcomes (1)
Self-reported change in alcohol consumption from baseline to 6 months post-treatment
Alcohol use will be assessed with the Timeline Followback (TLFB), a calendar-based measure that records standard drinks consumed each day in the past month to yield percent of drinking days, average drinks per drinking day, percent of heavy drinking (i.e., ≥4 drinks/occasion) days, and a variable indicating if alcohol use is above NIAAA-recommendations.
Measured: Baseline to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Katherine A Buckheit, PhD, Principal investigator, Veterans Health Research Institute of Central New York, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414589
- Sponsor's protocol ID
- 1825686
- Other IDs
- K01AA031524-01A1
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all data collection is complete and the coded database is finalized, IPD will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief, Integrated Intervention for Women Veterans With Unhealthy Alcohol Use in Primary Care
- ClinicalTrials.gov ID
- NCT07414589
- Acronym / sponsor ID
- 1825686
- Conditions
- Alcohol Misuse
- Keywords
- alcohol, integrated primary care, women Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 17 Feb 2026 (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.
The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. The main questions it aims to answer are:
- Is the treatment feasible and acceptable to women Veteran primary care patients?
- Can the treatment help reduce alcohol use, alcohol-related problems, and improve quality of life? Researchers will compare the new treatment to usual treatment that primary care patients would normally receive. Participants will be asked to participate in either the new behavioral treatment or usual primary care treatment and attend 3 appointments to answer questions about their alcohol use, quality of life, other mental health symptoms, and what they thought of their behavioral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief intervention for unhealthy alcohol use | Experimental | Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary CareParticipants in this arm will attend 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. All participants will attend 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns. |
| Usual Care | Active comparator | Behavioral: Primary care usual carePrimary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran status
- past-year Syracuse VAMC or community-based outpatient clinic (CBOC) primary care appointment
- identify as woman OR use women's PC services
- unhealthy alcohol use (AUDIT ≥ 7)
Key exclusion criteria (4 listed)
- current substance use treatment outside PC
- current psychosis, mania, or dementia (>10 on the BOMC)
- need for a higher level of alcohol or substance use care (detoxification, residential treatment) as indicated by a) patient preference b) withdrawal symptoms that indicate a need to monitor (≥23 on the AWSC) or high risk substance use (≥27 on the ASSIST)
- imminent risk of suicide.
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 |
|---|---|---|
| Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary CareThe intervention consists of 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. It includes 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use that have been adapted from existing evidence-based treatments in integrated primary care and specialty care. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns, including mood, trauma, sleep, and pain. | Behavioural | Brief intervention for unhealthy alcohol use |
| Primary care usual carePrimary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment | Behavioural | Usual Care |
Primary outcome
Change in self-reported quality of life from baseline to 6-months post-treatment
Time frame: From baseline to 6 months post-treatment
Quality of life will be assessed by the abbreviated World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report measure of QoL in the past 2 weeks in 4 areas (social, physical, psychological, and environment) on a 1-5 scale.
Change in self-reported alcohol-related problems from baseline to 6 months post-treatment
Time frame: From baseline to 6 months post-treatment
Alcohol problems will be assessed by the Short Inventory of Problems-Revised (SIP-R)147, a 17-item self-report measure of frequency of alcohol problems on a 0-3 scale.
Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment
Time frame: Baseline to 6 months post-treatment
Alcohol-specific functional impairment will be assessed by the Addiction Severity Index - Lite, a semi-structured interview developed among Veterans in substance use treatment that assesses alcohol and drug use and problems and 5 areas of functioning: medical, legal, psychiatric, employment, and family/social
Feasibility - average session length
Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.
Length of sessions in the experimental condition will be measured to test if the average is within guidelines for integrated primary care treatment (30 minutes maximum).
Intervention fidelity
Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.
An independent rater will listen to session tapes and record if each essential element was delivered on a checklist.
Self-reported patient acceptability of the experimental intervention
Time frame: After completing the behavioral health treatment, 8-12 weeks post-baseline.
Patient acceptability will be assessed with the Client Satisfaction Questionnaire (CSQ), an 8-item self-report measure. Acceptability ratings of at least "moderate" on the majority (5/8) of items on the CSQ will be considered acceptable.
1 secondary outcome
Self-reported change in alcohol consumption from baseline to 6 months post-treatment
Time frame: Baseline to 6 months post-treatment
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Once all data collection is complete and the coded database is finalized, IPD will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
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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.
Katherine A Buckheit, PhD principal investigator
Veterans Health Research Institute of Central New York, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care in people with Alcohol Misuse, run by Syracuse VA Medical Center 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Feb 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 Katherine A Buckheit, PhD (315-425-4400 ext. 56742, katheirne.buckheit@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported quality of life from baseline to 6-months post-treatment (time frame: From baseline to 6 months post-treatment). The study lists 6 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 17 Feb 2026.