Alcohol-induced DisordersPhase 1NCT05023317
Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
A Phase 1 study testing Strengths-based linkage to alcohol care in people with Alcohol-induced Disorders and Alcohol Drinking, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol-induced Disorders, Alcohol Drinking, Mental Health
- What is being tested?
- Strengths-based linkage to alcohol care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have screened positive for hazardous drinking (AUDIT-C score > 5)
- PTSD (PC-PTSD-5 score > 3) and/or depression (PHQ-2 score > 3) in the prior 12 months and have positive rescreens
- Not have received specialty SUD treatment or participated in weekly mutual-help groups in the past 90-days
- Not have significant cognitive impairment
- Have ongoing access to a mobile or landline telephone
- Provide at least one contact who will know the Veteran's contact information
Who cannot join
- Not meeting any of the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.
Read the detailed description
Background: It is important for Veterans with hazardous drinking to link to evidence-based alcohol care given high rates of comorbid mental health symptoms (PTSD, depression). Veterans with symptoms of PTSD who engage in hazardous drinking are at high risk for developing more severe drinking problems and depression. And Veterans with PTSD or depression are three to four times more likely to report hazardous drinking than Veterans without either of these disorders. This project will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC) to link Veterans, identified as hazardous drinkers in VHA primary care (PC), to alcohol care.
Significance/Impact: Existing VHA options, referral by a PC provider or mental health provider co-located in PC, for linking Veterans with hazardous drinking in PC to alcohol care are largely ineffective. Therefore, this proposal directly addresses HSR\&D priorities in the areas of Access to Care, Mental Health, and Primary Care by testing a novel approach to linking Veterans engaging in hazardous drinking, in the PC setting, to VA and non-VA alcohol care, to improve their drinking and mental health outcomes.
Innovation: This project is highly innovative because it offers a solution to the critical gap in VHA care in which PC patients with hazardous drinking are not receiving alcohol care. It tests a strategy to increase linkage to alcohol care that is both intensive enough to produce change, yet feasible to use in busy clinical settings with too-high demand on too-few staff members. In addition, the intervention proposed (SLAC) targets Veterans with the entire spectrum of hazardous drinking, including those with mental health symptoms. A highly innovative feature of SLAC is that it teaches PC providers how to link Veterans to evidence-based alcohol care instead of teaching providers how to treat hazardous drinking in the PC setting. Providers' lack of knowledge on how to treat hazardous alcohol use is a substantial obstacle to Veterans receiving alcohol care. Additional unique and innovative features of SLAC are that it uses patients' self-identified strengths, abilities, and skills to help them link to alcohol care.
Specific Aims: (Aim 1): To adapt SLAC for use among Veterans with hazardous drinking who may also have comorbid mental health symptoms, and for delivery by telephone in the VHA PC setting. The investigators will conduct qualitative interviews with Veterans, PC staff, and the VACO partners to ensure that the content and format of SLAC are adapted so they are relevant and acceptable to these stakeholders. (Aim 2): To determine (a) the feasibility of conducting a larger scale randomized controlled trial (RCT) to test SLAC's effectiveness and (b) SLAC's acceptability among hazardous drinking Veterans in PC, and to explore (c) the efficacy of SLAC among hazardous drinking Veterans in PC. To achieve Aim 2, the investigators will conduct a multi-site pilot RCT of SLAC at two VA medical facilities (Little Rock, AR and Palo Alto, CA). To achieve Aims 2a-b, the investigators will measure the feasibility (e.g., rates of enrollment and follow-up, fidelity to the SLAC intervention) of conducting a subsequent larger RCT (to test SLAC's effectiveness) and SLAC's acceptability (SLAC completion rates, satisfaction with SLAC) among Veterans. To achieve Aim 2c, the investigators will explore the efficacy of SLAC to improve Veterans' linkage and engagement in alcohol care, and their alcohol and mental health outcomes, at 3-month follow-up.
Methodology: The investigators will use (Aim 1) qualitative interviews to adapt SLAC for Veterans and for the PC setting, and (Aim 2) conduct a multi-site, pilot RCT.
Implementation/Next Steps: Should the findings justify a subsequent project, the investigators plan to propose a fully powered, multi-site study, using a Hybrid design, to test SLAC's clinical effectiveness when delivered in VHA PC while observing and gathering information on the implementation potential of SLAC in this setting.
- Conditions
- Alcohol-induced Disorders, Alcohol Drinking, Mental Health
- Being tested
- Strengths-based linkage to alcohol care, Usual care
- Keywords
- referral and consultation, psychosocial intervention
- Medical subject headings
- Alcohol-Induced Disorders, Alcohol Drinking, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengths-based linkage to alcohol careBehavioural
Also called SLAC
SLAC is a behavioral intervention designed to link persons with substance use/misuse to care
Usual careBehavioural
Usual care consists of brief screening and intervention and/or standard referral to alcohol care
| Study group | Role | What they receive |
|---|---|---|
| Strengths-based linkage to alcohol care (SLAC) | Experimental | SLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option Receives: Behavioral: Strengths-based linkage to alcohol care |
| Usual care | Active comparator | Usual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy) Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to alcohol care
This outcome is a dichotomous variable (yes/no), with "yes" defined as the participant reporting at least one of the following: attended an initial meeting with an outpatient (primary care, specialty care) or residential program; attended a mutual-help group meeting; received > 30-days' supply of AUD medication; or went online to access e-health for alcohol information.
Measured: 3-month
Utilization of alcohol care
The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care.
Measured: 3-month
Utilization of alcohol care options
We will measure the total number of alcohol care options participants obtained over the past 90-days; scores will range from 0 (no care) to 4 (obtained all types of care: outpatient/residential, mutual-help, medication (>30-days' supply), e-health).
Measured: 3-month
Secondary outcomes (3)
Alcohol consumption
The quantity and frequency of alcohol consumed will be measured using the 90-day Time Line Follow-Back (TLFB) instrument. The TLFB is a calendar that tracks alcohol consumed each day. We will combine frequency data (days of alcohol consumed) and quantity data (number of drinks consumed each day) to derive a variable measuring harmful drinking days - or days in which alcohol consumed is above NIAAA recommended limits for men and women.
Measured: 3-month
Depression
Depression severity will be measured using the Patient Health Questionnaire-9. Scores range from 0-27. Higher scores indicate more symptoms of depression.
Measured: 3-month
Posttraumatic stress disorder
Posttraumatic stress disorder severity will be measured using the PTSD Checklist-5. Scores range from 0-80, with higher scores indicating more symptoms of PTSD.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol-induced DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two conditions-(a) strengths based linkage to alcohol care plus usual care or (b) usual care only
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael A Cucciare, PhD, Principal investigator, Central Arkansas Veterans Healthcare System , Little Rock, ARKeith N. Humphreys, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023317
- Sponsor's protocol ID
- IIR 20-058
- Status last verified
- Jan 2026
- First submitted
- 17 Aug 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets meeting VA standards for disclosure to the public will be made available post-publication. Prior to distribution, a local privacy officer will certify that all datasets do not contain PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.
Publications
Cucciare MA, Marchant K, Benton C, Hildebrand D, Ghaus S, Han X, Thompson RG, Timko C. Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression symptoms. Addict Sci Clin Pract. 2023 Aug 17;18(1):50. doi: 10.1186/s13722-023-00403-z.
PubMed 37592359Cucciare MA, Benton C, Hildebrand D, Marchant K, Ghaus S, Han X, Williams JS, Thompson RG, Timko C. Adapting an Alcohol Care Linkage Intervention to US Military Veterans Presenting to Primary Care with Hazardous Drinking and PTSD and/or Depression Symptoms: A Qualitative Study. J Clin Psychol Med Settings. 2024 Jun;31(2):417-431. doi: 10.1007/s10880-023-09986-w. Epub 2023 Dec 15.
PubMed 38100057
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
- ClinicalTrials.gov ID
- NCT05023317
- Acronym / sponsor ID
- IIR 20-058
- Conditions
- Alcohol-induced Disorders, Alcohol Drinking, Mental Health
- Keywords
- referral and consultation, psychosocial intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Aug 2021 (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.
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.
Detailed description
Background: It is important for Veterans with hazardous drinking to link to evidence-based alcohol care given high rates of comorbid mental health symptoms (PTSD, depression). Veterans with symptoms of PTSD who engage in hazardous drinking are at high risk for developing more severe drinking problems and depression. And Veterans with PTSD or depression are three to four times more likely to report hazardous drinking than Veterans without either of these disorders. This project will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC) to link Veterans, identified as hazardous drinkers in VHA primary care (PC), to alcohol care.
Significance/Impact: Existing VHA options, referral by a PC provider or mental health provider co-located in PC, for linking Veterans with hazardous drinking in PC to alcohol care are largely ineffective. Therefore, this proposal directly addresses HSR\&D priorities in the areas of Access to Care, Mental Health, and Primary Care by testing a novel approach to linking Veterans engaging in hazardous drinking, in the PC setting, to VA and non-VA alcohol care, to improve their drinking and mental health outcomes.
Innovation: This project is highly innovative because it offers a solution to the critical gap in VHA care in which PC patients with hazardous drinking are not receiving alcohol care. It tests a strategy to increase linkage to alcohol care that is both intensive enough to produce change, yet feasible to use in busy clinical settings with too-high demand on too-few staff members. In addition, the intervention proposed (SLAC) targets Veterans with the entire spectrum of hazardous drinking, including those with mental health symptoms. A highly innovative feature of SLAC is that it teaches PC providers how to link Veterans to evidence-based alcohol care instead of teaching providers how to treat hazardous drinking in the PC setting. Providers' lack of knowledge on how to treat hazardous alcohol use is a substantial obstacle to Veterans receiving alcohol care. Additional unique and innovative features of SLAC are that it uses patients' self-identified strengths, abilities, and skills to help them link to alcohol care.
Specific Aims: (Aim 1): To adapt SLAC for use among Veterans with hazardous drinking who may also have comorbid mental health symptoms, and for delivery by telephone in the VHA PC setting. The investigators will conduct qualitative interviews with Veterans, PC staff, and the VACO partners to ensure that the content and format of SLAC are adapted so they are relevant and acceptable to these stakeholders. (Aim 2): To determine (a) the feasibility of conducting a larger scale randomized controlled trial (RCT) to test SLAC's effectiveness and (b) SLAC's acceptability among hazardous drinking Veterans in PC, and to explore (c) the efficacy of SLAC among hazardous drinking Veterans in PC. To achieve Aim 2, the investigators will conduct a multi-site pilot RCT of SLAC at two VA medical facilities (Little Rock, AR and Palo Alto, CA). To achieve Aims 2a-b, the investigators will measure the feasibility (e.g., rates of enrollment and follow-up, fidelity to the SLAC intervention) of conducting a subsequent larger RCT (to test SLAC's effectiveness) and SLAC's acceptability (SLAC completion rates, satisfaction with SLAC) among Veterans. To achieve Aim 2c, the investigators will explore the efficacy of SLAC to improve Veterans' linkage and engagement in alcohol care, and their alcohol and mental health outcomes, at 3-month follow-up.
Methodology: The investigators will use (Aim 1) qualitative interviews to adapt SLAC for Veterans and for the PC setting, and (Aim 2) conduct a multi-site, pilot RCT.
Implementation/Next Steps: Should the findings justify a subsequent project, the investigators plan to propose a fully powered, multi-site study, using a Hybrid design, to test SLAC's clinical effectiveness when delivered in VHA PC while observing and gathering information on the implementation potential of SLAC in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two conditions-(a) strengths based linkage to alcohol care plus usual care or (b) usual care only
| Arm | Type | Receives |
|---|---|---|
| Strengths-based linkage to alcohol care (SLAC) | Experimental | Behavioral: Strengths-based linkage to alcohol careSLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option |
| Usual care | Active comparator | Behavioral: Usual careUsual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have screened positive for hazardous drinking (AUDIT-C score > 5)
- PTSD (PC-PTSD-5 score > 3) and/or depression (PHQ-2 score > 3) in the prior 12 months and have positive rescreens
- Not have received specialty SUD treatment or participated in weekly mutual-help groups in the past 90-days
- Not have significant cognitive impairment
- Have ongoing access to a mobile or landline telephone
Key exclusion criteria (1 listed)
- Not meeting any of the inclusion criteria
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 |
|---|---|---|
| Strengths-based linkage to alcohol careAlso: SLACSLAC is a behavioral intervention designed to link persons with substance use/misuse to care | Behavioural | Strengths-based linkage to alcohol care (SLAC) |
| Usual careUsual care consists of brief screening and intervention and/or standard referral to alcohol care | Behavioural | Usual care |
Primary outcome
Linkage to alcohol care
Time frame: 3-month
This outcome is a dichotomous variable (yes/no), with "yes" defined as the participant reporting at least one of the following: attended an initial meeting with an outpatient (primary care, specialty care) or residential program; attended a mutual-help group meeting; received > 30-days' supply of AUD medication; or went online to access e-health for alcohol information.
Utilization of alcohol care
Time frame: 3-month
The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care.
Utilization of alcohol care options
Time frame: 3-month
We will measure the total number of alcohol care options participants obtained over the past 90-days; scores will range from 0 (no care) to 4 (obtained all types of care: outpatient/residential, mutual-help, medication (>30-days' supply), e-health).
3 secondary outcomes
Alcohol consumption
Time frame: 3-month
Depression
Time frame: 3-month
Posttraumatic stress disorder
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 37592359Cucciare MA, Marchant K, Benton C, Hildebrand D, Ghaus S, Han X, Thompson RG, Timko C. Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression symptoms. Addict Sci Clin Pract. 2023 Aug 17;18(1):50. doi: 10.1186/s13722-023-00403-z.
- Results publication: PubMed 38100057Cucciare MA, Benton C, Hildebrand D, Marchant K, Ghaus S, Han X, Williams JS, Thompson RG, Timko C. Adapting an Alcohol Care Linkage Intervention to US Military Veterans Presenting to Primary Care with Hazardous Drinking and PTSD and/or Depression Symptoms: A Qualitative Study. J Clin Psychol Med Settings. 2024 Jun;31(2):417-431. doi: 10.1007/s10880-023-09986-w. Epub 2023 Dec 15.
- Individual participant dataSharing planned: Yes. Datasets meeting VA standards for disclosure to the public will be made available post-publication. Prior to distribution, a local privacy officer will certify that all datasets do not contain PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.
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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. This study is not recruiting at the moment.
Michael A Cucciare, PhD principal investigator
Central Arkansas Veterans Healthcare System , Little Rock, AR
Keith N. Humphreys, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Strengths-based linkage to alcohol care in people with Alcohol-induced Disorders and Alcohol Drinking, run by VA Office of Research and Development at 2 sites 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to alcohol care (time frame: 3-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023317, which also lists 2 linked publications.
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 13 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.