Unhealthy Alcohol UseNCT07782307
Brief Alcohol Treatment for Women Veterans in Primary Care - Open Trial
A study testing Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care in people with Unhealthy Alcohol Use, run by Syracuse VA Medical Center.
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 an open trial phase to test the intervention with a small number of participants and revise the intervention based on experience and feedback. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Unhealthy Alcohol Use
- 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
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 an open trial phase to test the intervention with a small number of participants and revise the intervention based on experience and feedback. 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 deliver the intervention to women Veterans with unhealthy alcohol use in primary care. Participants will be asked to participate in the new behavioral treatment and attend 2 appointments to answer questions about their alcohol use, quality of life, other mental health symptoms, and what they thought of their behavioral treatment.
- Conditions
- Unhealthy Alcohol Use
- Being tested
- Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary 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 4-9 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 5 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.
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention for unhealthy alcohol use | Experimental | Participants in this arm will attend 4-9 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 5 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 |
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 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. Higher scores indicate better quality of life.
Measured: Baseline to post-treatment (approximately 8-12 weeks after baseline)
Change in self-reported alcohol-related problems from baseline to 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. Higher scores indicate more frequent alcohol-related problems.
Measured: From baseline to post-treatment (approximately 8-12 weeks after baseline)
Change in self-reported alcohol-related functional impairment from baseline to 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. Higher scores indicate greater alcohol-related functional impairment.
Measured: Baseline to post-treatment (approximately 8-12 weeks after baseline)
Feasibility - average session length
Length of sessions 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, 8-18 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, 8-18 weeks post-baseline
Self-reported patient acceptability of the 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, 8-18 weeks post-baseline
Secondary outcomes (1)
Self-reported change in alcohol consumption from baseline to 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 post-treatment (approximately 8-12 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unhealthy Alcohol UseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782307
- Sponsor's protocol ID
- K01AA031524-01A1
- Other IDs
- K01AA031524-01A1
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 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 24 Aug 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
- NCT07782307
- Acronym / sponsor ID
- K01AA031524-01A1
- Conditions
- Unhealthy Alcohol Use
- Keywords
- alcohol, integrated primary care, women Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Aug 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 an open trial phase to test the intervention with a small number of participants and revise the intervention based on experience and feedback. 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 deliver the intervention to women Veterans with unhealthy alcohol use in primary care. Participants will be asked to participate in the new behavioral treatment and attend 2 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 4-9 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 5 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns. |
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 4-9 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 5 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 outcome
Change in self-reported quality of life from baseline to post-treatment
Time frame: Baseline to post-treatment (approximately 8-12 weeks after baseline)
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. Higher scores indicate better quality of life.
Change in self-reported alcohol-related problems from baseline to post-treatment
Time frame: From baseline to post-treatment (approximately 8-12 weeks after baseline)
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. Higher scores indicate more frequent alcohol-related problems.
Change in self-reported alcohol-related functional impairment from baseline to post-treatment
Time frame: Baseline to post-treatment (approximately 8-12 weeks after baseline)
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. Higher scores indicate greater alcohol-related functional impairment.
Feasibility - average session length
Time frame: For the duration of the intervention period, 8-18 weeks post-baseline
Length of sessions 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, 8-18 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 intervention
Time frame: After completing the behavioral health treatment, 8-18 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 post-treatment
Time frame: Baseline to post-treatment (approximately 8-12 weeks after baseline).
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 24 Aug 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.
Related trials for Unhealthy Alcohol Use
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Active, not recruiting
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
HIV-1-infection, Unhealthy Alcohol Use
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
Recruiting
Supporting Health Through Alcohol Reduction and Relationship Enhancement Together
Unhealthy Alcohol Use
Not yet recruiting
Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial
Metabolic Syndrome, Inactivity/Low Levels of Exercise
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.
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 Unhealthy Alcohol Use, run by Syracuse VA Medical Center.
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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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, katherine.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 post-treatment (time frame: Baseline to post-treatment (approximately 8-12 weeks after baseline)). 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 24 Aug 2026.