NCT05023317

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

August 17, 2021

Last Update Submit

January 9, 2026

Conditions

Alcohol-induced DisordersAlcohol DrinkingMental Health

Keywords

referral and consultationpsychosocial intervention

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    3-month

Secondary Outcomes (3)

  • Alcohol consumption

    3-month

  • Depression

    3-month

  • Posttraumatic stress disorder

    3-month

Study Arms (2)

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

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)

Behavioral: Usual care

Interventions

Strengths-based linkage to alcohol careBEHAVIORAL

SLAC is a behavioral intervention designed to link persons with substance use/misuse to care

Also known as: SLAC
Strengths-based linkage to alcohol care (SLAC)
Usual careBEHAVIORAL

Usual care consists of brief screening and intervention and/or standard referral to alcohol care

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, 72205, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (2)

  • 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.

    PMID: 37592359RESULT

  • Cucciare 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.

    PMID: 38100057RESULT

MeSH Terms

Conditions

Alcohol-Induced DisordersAlcohol DrinkingPsychological Well-Being

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersDrinking BehaviorBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Michael A Cucciare, PhD

    Central Arkansas Veterans Healthcare System , Little Rock, AR

    PRINCIPAL INVESTIGATOR

  • Keith N. Humphreys, PhD MA

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Research assistants, blinded to condition, will collect baseline and 3-month follow-up data from participants. The investigators will also be blinded to participant group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two conditions-(a) strengths based linkage to alcohol care plus usual care or (b) usual care only
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 26, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available following publication of the study results
Access Criteria
see above

Locations

US(2)