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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Veterans 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.
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.
- First posted10 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mark Vander Weg, Iowa City Veterans Affairs Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Related Risk Reduction in Rural Veterans
- ClinicalTrials.gov ID
- NCT06768684
- Acronym / sponsor ID
- NOMAD 4130
- Conditions
- Alcohol Use
- Keywords
- alcohol, harm reduction, behavioral intervention, Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Study start
- Jan 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jan 2025 (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 project is designed to refine and evaluate the feasibility and preliminary effectiveness of a brief, telephone-administered alcohol risk reduction intervention for Veterans.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: Brief behavioral counselingVeterans will receive a two-session telephone-administered alcohol risk reduction intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veteran status, English-speaking, report current alcohol use, receiving treatment through the Iowa City VA Health Care System
Key exclusion criteria (1 listed)
- History of significant alcohol withdrawal, evidence of significant alcohol dependence, lack of regular access to a telephone, inability to participate in phone counseling
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 |
|---|---|---|
| Brief behavioral counselingParticipants 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. | Behavioural | Active intervention |
Primary outcome
Alcohol consumption
Time frame: 30-days
Past 30-day alcohol consumption will be assessed using the Alcohol Timeline Follow-back method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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.