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Alcohol UseNCT06768684

Alcohol Related Risk Reduction in Veterans

A study testing Brief behavioral counseling in people with Alcohol Use, run by Iowa City Veterans Affairs Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This project is designed to refine and evaluate the feasibility and preliminary effectiveness of a brief, telephone-administered alcohol risk reduction intervention for Veterans. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use
What is being tested?
Brief behavioral counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jan 2025to 30 Dec 2026
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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran status, English-speaking, report current alcohol use, receiving treatment through the Iowa City VA Health Care System

Who cannot join

  • History of significant alcohol withdrawal, evidence of significant alcohol dependence, lack of regular access to a telephone, inability to participate in phone counseling

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mark Vander Weg Investigator, PhD contact

319-467-1377

mark.vanderweg@va.gov

David Hernandez Project Coordinator, BA contact

319-338-0581 ext. 63-7555

david.hernandez3@va.gov

About this study

Official title: Alcohol Related Risk Reduction in Rural Veterans

This project is designed to refine and evaluate the feasibility and preliminary effectiveness of a brief, telephone-administered alcohol risk reduction intervention for Veterans.

Read the detailed description

This study will investigate whether a brief alcohol harm reduction intervention for Veteran primary care patients who consume alcohol at levels that exceed dietary guidelines but who do not necessarily exhibit evidence of alcohol use and dependence is feasible based on enrollment and retention rates, and treatment satisfaction. In addition, we will investigate whether there is preliminary evidence for efficacy of the intervention based on changes in alcohol consumption over time.

Following enrollment in the study, participants will be scheduled for an initial phone session. Veterans will then receive an alcohol risk reduction intervention that is based on VA/DoD Clinical Practice Guidelines and strategies recommended by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The intervention will be delivered via telephone. After an introduction and overview of the intervention, Veterans will be provided with personalized feedback regarding potential health risks associated with their alcohol use and how alcohol use may interact with their health conditions and medications. Following a motivational enhancement exercise, Veterans are advised to reduce alcohol intake to within recommended limits and are supported in identifying a drinking goal. Consistent with principles of harm reduction, the approach starts by "meeting the Veteran where they are" and establishing a collaborative and empowering relationship that leverages the individual's skills. Rather than requiring participants to work toward abstinence, Veterans select their own treatment goals. Evidence-based strategies for achieving the goal are discussed (e.g., goal setting, self-monitoring, identifying and avoiding triggers, dealing with urges, pacing and spacing drinks, managing high risk situations, finding alternatives to alcohol, developing refusal skills, and enlisting social support). Educational materials addressing methods for cutting down are also provided, along with information about other available resources to support their efforts. Progress is monitored at a subsequent contact. Small, incremental gains are reinforced and recognized as steps in the right direction. Problem solving is used to address barriers to change, and revised goals are discussed as appropriate.

Participants will complete baseline questionnaires as well as a post-treatment evaluations (at approximately three months) and follow-up questionnaires at six months post baseline. Data collection will occur by phone unless the participant requests a hard copy survey to be mailed.

Some study participants will also be selected for a separate phone call to ask additional questions about their experience with the coaching sessions, such as what they liked and didn't like about the phone calls, and what things about them were the most and least helpful.

Conditions
Alcohol Use
Being tested
Brief behavioral counseling
Keywords
alcohol, harm reduction, behavioral intervention, Veterans
Medical subject headings
Alcohol Drinking, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief behavioral counselingBehavioural

    Participants receive a two-session phone-based alcohol risk reduction intervention based on principles of harm reduction. Participants receive personalized feedback regarding how alcohol use may impact their health. Following a motivational enhancement exercise, participants are advised to reduce alcohol intake to within recommended limits. Evidence-based strategies are discussed (e.g., goal setting, self-monitoring, identifying and avoiding triggers, dealing with urges, pacing and spacing drinks, managing high risk situations, finding alternatives to alcohol, developing refusal skills, and enlisting social support). Educational materials addressing methods for cutting down are also provided, along with information about other available resources to support their efforts.

Study groups in NCT06768684
Study groupRoleWhat they receive
Active interventionExperimentalVeterans will receive a two-session telephone-administered alcohol risk reduction intervention.
Receives: Behavioral: Brief behavioral counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol consumption

    Past 30-day alcohol consumption will be assessed using the Alcohol Timeline Follow-back method.

    Measured: 30-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768684
Sponsor's protocol ID
NOMAD 4130
Status last verified
Jan 2025
First submitted
6 Jan 2025
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Brief behavioral counseling in people with Alcohol Use, run by Iowa City Veterans Affairs 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 1 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: opening soon, as of the sponsor's last update on 10 Jan 2025. 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 Mark Vander Weg Investigator, PhD (319-467-1377, mark.vanderweg@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol consumption (time frame: 30-days). 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 10 Jan 2025.

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