Recruiting

Telehealth

Sponsor:

Medical University of South Carolina

Code:

NCT05674409

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Brief Family-Involved Treatment (B-FIT)

Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Study Details

Brief summary:

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans.

The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy.

This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual (TAU), (in this case B-FIT+ Cognitive Behavioral Therapy treatment) as compared to TAU alone (CBT treatment).Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 \& 6 month follow-up assessments, all via telehealth.

Conditions

Alcohol Use Disorder

Study ID

NCT05674409

Start date

Mar 13, 2023

Status verified date

Feb, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants will be 200 Veterans and a family member, plus their treatment companion, a concerned partner or friend (total N=400; 50% women veterans) aged 21 or older.

Inclusion criteria for Veterans require that they:

1. Meet diagnostic criteria for current moderate to severe alcohol use disorder (AUD) with 2 or more heavy drinking days (>5 for men, >4 for women) in the 60 days prior to enrollment
2. Have an adult family member/treatment companion who is willing to participate
3. Demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (≥ 26 on the Mini-Mental Status Exam \[MMSE\])
4. Maintain a stable dose of psychotropic medications for at least 4 weeks before enrollment. Concurrent drug use disorders are acceptable provided alcohol is the Veteran's primary substance of choice. Drug use will be measured weekly and controlled for in statistical analyses if needed.

Inclusion criteria for the family member/treatment companion require that they:

1. Are not receiving or seeking treatment for their own alcohol or drug problem
2. Report total Alcohol Use Disorders Identification Test (AUDIT) scores <8
3. Report total Drug Abuse Screening Test (DAST-10) scores <3.

Exclusion Criteria:

Exclusion criteria for all participants include:

1. History of or current psychotic or bipolar disorder
2. Alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score >8)
3. Current suicidal or homicidal ideation and intent
4. Severe or unilateral violence in the past 6 months as measured by the Revised Conflict Tactics Scale (CTS2) (consistent with extant dyadic treatment literature).

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy + Brief Family-Involved Treatment

Approximately half of enrolled veterans and their treatment companion will be randomly assigned to the experimental group. The identified veteran participant wil receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD). In addition, both the identified veteran and their treatment companion will receive an additional 3 sessions of Brief Family-Involved Treatment (B-FIT).

B-FIT is a manualized, 3-session AUD intervention, designed to be implemented in combination with any existing alcohol treatment program.

active comparator: Cognitive Behavioral Therapy

Approximately half of enrolled veterans and their treatment companion will be randomly assigned to the active comparator group. The identified veteran participant wil receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).

Interventions

Brief Family-Involved Treatment (B-FIT)

Brief Family-Involved Treatment (B-FIT) is a manualized, 3-session intervention for Alcohol Use Disorder (AUD). Designed to be implemented in combination with any existing alcohol treatment program, the goals of B-FIT are to (1) increase reinforcement for AUD treatment engagement, (2) increase positive rewards from drinking reductions, and (3) decrease drinking cues by decreasing negative communication and increasing positive communication.

Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).

Primary outcome measure

  • Family functioning [ Time Frame: From baseline to week 12 ]
  • Change in Alcohol Consumption [ Time Frame: From baseline to week 12 ]
  • Change in percent days drinking [ Time Frame: From baseline to week 12 ]
  • Change in drinks per drinking day [ Time Frame: From baseline to week 12 ]
  • Alcohol problem severity [ Time Frame: From baseline to week 12 ]
  • Change in alcohol craving [ Time Frame: From baseline to week 12 ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Julianne Flanagan, PhD

843-792-5569hellmuth@musc.edu

Principal Investigator:

Julianne Flanagan, Ph.D

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-05.