NCT01707030

Brief Summary

Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other populations. The research team will evaluate whether the program helps Veterans drink less over time and thereby improve their health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

October 3, 2012

Results QC Date

August 27, 2019

Last Update Submit

March 13, 2025

Conditions

Keywords

clinical trialveteransubstance use disorder

Outcome Measures

Primary Outcomes (2)

  • Change in Days of Unhealthy Alcohol Consumption

    The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.

    Baseline, 3 months, and 6 months

  • Change in Drinking Days

    The number of days on which alcohol was consumed at any level in the last 30 days.

    Baseline, 3 months, and 6 months

Secondary Outcomes (4)

  • Change in Drinks Per Drinking Day

    Baseline, 3 months, and 6 months

  • Change in Symptoms of Psychological Distress (PHQ-9)

    Baseline, 3 months, and 6 months

  • Change in SF-12 Physical Health Composite

    Baseline, 3 months, and 6 months

  • Change in Additional Care

    Baseline and 12 months

Other Outcomes (1)

  • Change in SF-12 Mental Health Composite

    Baseline, 3 months, and 6 months

Study Arms (2)

BAI Arm

EXPERIMENTAL

Receiving a web-based brief intervention for alcohol problems

Other: Web-Based Brief Alcohol InterventionOther: Usual Care

Usual Care

ACTIVE COMPARATOR

In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls

Other: Usual Care

Interventions

Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.

BAI Arm

All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

BAI ArmUsual Care

Eligibility Criteria

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

You may qualify if:

  • Must be a US military veteran.
  • Over the age of 17 with liver disease.
  • Must be receiving care at a VA liver clinic.

You may not qualify if:

  • Those with no current or historical use of alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (6)

  • Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.

    PMID: 26467975BACKGROUND
  • Cucciare MA, Timko C. Bridging the gap between medical settings and specialty addiction treatment. Addiction. 2015 Sep;110(9):1417-9. doi: 10.1111/add.12977. No abstract available.

  • Cucciare MA, Cheung RC, Rongey C. Treating substance use disorders in patients with hepatitis C. Addiction. 2015 Jul;110(7):1057-9. doi: 10.1111/add.12893. Epub 2015 Mar 27. No abstract available.

  • Timko C, Kong C, Vittorio L, Cucciare MA. Screening and brief intervention for unhealthy substance use in patients with chronic medical conditions: a systematic review. J Clin Nurs. 2016 Nov;25(21-22):3131-3143. doi: 10.1111/jocn.13244. Epub 2016 May 3.

  • Cucciare MA, Jamison AL, Combs AS, Joshi G, Cheung RC, Rongey C, Huggins J, Humphreys K. Adapting a computer-delivered brief alcohol intervention for veterans with Hepatitis C. Inform Health Soc Care. 2017 Dec;42(4):378-392. doi: 10.1080/17538157.2016.1255628. Epub 2017 Jan 9.

  • Cucciare MA, Combs AS, Joshi G, Han X, Humphreys K. Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial. Addiction. 2021 May;116(5):1076-1087. doi: 10.1111/add.15263. Epub 2020 Oct 6.

MeSH Terms

Conditions

Hepatitis CAlcoholismSubstance-Related Disorders

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesAlcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Results Point of Contact

Title
Dr. Micheal Cucciare
Organization
Department of Veterans Affairs

Study Officials

  • Keith N. Humphreys, PhD MA

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR
  • Michael A Cucciare, PhD

    Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 15, 2012

Study Start

March 1, 2015

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

March 21, 2025

Results First Posted

September 25, 2019

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations