Alcohol DrinkingASPIRE-2NCT05783635
Alcohol Screening and Preoperative Intervention Research Study - 2
A study testing Preoperative Virtual Health Coaching, Usual surgical care (post-operative) and Postoperative Virtual Health Coaching in people with Alcohol Drinking, run by University of Michigan at 1 site in United States.
Trial summary
This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Preoperative Virtual Health Coaching, Usual surgical care (post-operative) and Postoperative Virtual Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 28 Feb 2027
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed consent form, baseline survey, and enrollment phone call
- Willingness to comply with all study procedures and availability for the duration of the study
- Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
- Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
- Access to a smart device or computer access with internet or wi-fi connection throughout the study period
Who cannot join
- Exclude participants enrolled in another research study focused on alcohol use
- History of severe alcohol withdrawal
- Unable to speak, understand, or read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.
- Conditions
- Alcohol Drinking
- Being tested
- Enhanced Usual Care (pre-operative), Preoperative Virtual Health Coaching, Usual surgical care (post-operative), Postoperative Virtual Health Coaching, On-Track (Post-operative)
- Keywords
- Surgery
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (pre-operative)Behavioural
The enhanced usual care will receive standard surgical care, and a resource brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. The resource brochure will be e-mailed to patients or sent via postal mail.
Preoperative Virtual Health CoachingBehavioural
Preoperative Virtual Coaching is based on principles of health coaching, collaborative care, and motivational interviewing. Health and educational content is framed using the Health Belief Model. During two sessions, that take place approximately 3 and 5 weeks prior to surgery, the health coach presents alcohol use reduction/abstinence as important for surgical health (rather than addiction or chronic health reasons) and engages participants in discussion and patient-centered goal-setting.
Participants will also receive a brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources.
Usual surgical care (post-operative)Behavioural
This group will receive standard post-operative care.
Postoperative Virtual Health CoachingBehavioural
Postoperative Virtual Coaching uses the same framework and structure as Preoperative Virtual Coaching. These sessions will be delivered by a health coach using a collaborative, and motivational interviewing-based approach. The goal of these sessions is to promote well-being and help participants maintain alcohol abstinence or reduction long-term (or initiate change in alcohol use if they have not already). These sessions promote low-risk alcohol use, provide education on chronic health effects of heavy alcohol use, and teach skills for coping with or avoiding triggers for alcohol use including coping with stress and mood challenges. These sessions introduce skills to help participants manage alcohol, stress, and mood as they recover from surgery.
On-Track (Post-operative)Behavioural
On-Track is a mobile and web-accessible health tool that uses self-monitoring and provision of feedback on progress towards goals to engage participants in self-management of alcohol use and motivate behavior change through increased self-awareness and accountability for health.
The On-Track application includes a) daily tracking of alcohol and other substance use; b) daily tracking of stress, mood, and pain; c) personalized health goals; and d) visual displays of alcohol use, stress, mood, pain, and goal achievement including graphs of trends over time.
On-Track also uses novel monetary and non-monetary incentives to encourage utilization including an escalating monetary incentive schedule for self-monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care then Usual Surgical Care | Experimental | Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (pre-operative); Behavioral: Usual surgical care (post-operative) |
| Enhanced Usual Care then Post-operative Health Coaching | Experimental | Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (pre-operative); Behavioral: Postoperative Virtual Health Coaching |
| Enhanced Usual Care then On-Track | Experimental | Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (pre-operative); Behavioral: On-Track (Post-operative) |
| Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track) | Experimental | Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (pre-operative); Behavioral: Postoperative Virtual Health Coaching; Behavioral: On-Track (Post-operative) |
| Enhanced Usual Care alone | Other | Only completed first randomization. Study withdrawal prior to re-randomization Receives: Behavioral: Enhanced Usual Care (pre-operative) |
| Preoperative Virtual Health Coaching then Usual Surgical Care | Experimental | Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching Receives: Behavioral: Preoperative Virtual Health Coaching; Behavioral: Usual surgical care (post-operative) |
| Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching | Experimental | Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching Receives: Behavioral: Preoperative Virtual Health Coaching; Behavioral: Postoperative Virtual Health Coaching |
| Preoperative Virtual Health Coaching then On-Track | Experimental | Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching Receives: Behavioral: Preoperative Virtual Health Coaching; Behavioral: On-Track (Post-operative) |
| Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track) | Experimental | Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching Receives: Behavioral: Preoperative Virtual Health Coaching; Behavioral: Postoperative Virtual Health Coaching; Behavioral: On-Track (Post-operative) |
| Preoperative Virtual Health Coaching only | Other | Only completed first randomization. Study withdrawal prior to re-randomization. Receives: Behavioral: Preoperative Virtual Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption as measured by the timeline follow-back
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.
Measured: 10 months after surgical discharge
Secondary outcomes (2)
World Health Organization Drinking (WHO) Risk Level
WHO drinking risk levels derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).
Measured: 10 months after surgical discharge
Alcohol Use Disorder Identification test (AUDIT)
We will calculate participant's total score on the AUDIT measure. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use and presence of more alcohol use disorder symptoms.
Measured: Up to 10 months after surgical discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start17 Apr 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Coughlin, University of Michigan
- Investigators
- Lara Coughlin, PhD, Principal investigator, University of MichiganAnne Fernandez, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783635
- Sponsor's protocol ID
- HUM00208317
- Other IDs
- R01AA029666
- Acronym
- ASPIRE-2
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
- ClinicalTrials.gov ID
- NCT05783635
- Acronym / sponsor ID
- ASPIRE-2 / HUM00208317
- Conditions
- Alcohol Drinking
- Keywords
- Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Mar 2023 (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 sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
- Model description
- The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care then Usual Surgical Care | Experimental | Behavioral: Enhanced Usual Care (pre-operative), Behavioral: Usual surgical care (post-operative)Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care |
| Enhanced Usual Care then Post-operative Health Coaching | Experimental | Behavioral: Enhanced Usual Care (pre-operative), Behavioral: Postoperative Virtual Health CoachingRandomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care |
| Enhanced Usual Care then On-Track | Experimental | Behavioral: Enhanced Usual Care (pre-operative), Behavioral: On-Track (Post-operative)Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care |
| Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track) | Experimental | Behavioral: Enhanced Usual Care (pre-operative), Behavioral: Postoperative Virtual Health Coaching, Behavioral: On-Track (Post-operative)Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care |
| Enhanced Usual Care alone | Other | Behavioral: Enhanced Usual Care (pre-operative)Only completed first randomization. Study withdrawal prior to re-randomization |
| Preoperative Virtual Health Coaching then Usual Surgical Care | Experimental | Behavioral: Preoperative Virtual Health Coaching, Behavioral: Usual surgical care (post-operative)Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching |
| Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching | Experimental | Behavioral: Preoperative Virtual Health Coaching, Behavioral: Postoperative Virtual Health CoachingRandomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching |
| Preoperative Virtual Health Coaching then On-Track | Experimental | Behavioral: Preoperative Virtual Health Coaching, Behavioral: On-Track (Post-operative)Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching |
| Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track) | Experimental | Behavioral: Preoperative Virtual Health Coaching, Behavioral: Postoperative Virtual Health Coaching, Behavioral: On-Track (Post-operative)Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching |
| Preoperative Virtual Health Coaching only | Other | Behavioral: Preoperative Virtual Health CoachingOnly completed first randomization. Study withdrawal prior to re-randomization. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed consent form, baseline survey, and enrollment phone call
- Willingness to comply with all study procedures and availability for the duration of the study
- Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
- Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
- Access to a smart device or computer access with internet or wi-fi connection throughout the study period
Key exclusion criteria (3 listed)
- Exclude participants enrolled in another research study focused on alcohol use
- History of severe alcohol withdrawal
- Unable to speak, understand, or read English
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 |
|---|---|---|
| Enhanced Usual Care (pre-operative)The enhanced usual care will receive standard surgical care, and a resource brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. The resource brochure will be e-mailed to patients or sent via postal mail. | Behavioural | Enhanced Usual Care alone, Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track), Enhanced Usual Care then On-Track, Enhanced Usual Care then Post-operative Health Coaching, Enhanced Usual Care then Usual Surgical Care |
| Preoperative Virtual Health CoachingPreoperative Virtual Coaching is based on principles of health coaching, collaborative care, and motivational interviewing. Health and educational content is framed using the Health Belief Model. During two sessions, that take place approximately 3 and 5 weeks prior to surgery, the health coach presents alcohol use reduction/abstinence as important for surgical health (rather than addiction or chronic health reasons) and engages participants in discussion and patient-centered goal-setting. Participants will also receive a brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. | Behavioural | Preoperative Virtual Health Coaching only, Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track), Preoperative Virtual Health Coaching then On-Track, Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching, Preoperative Virtual Health Coaching then Usual Surgical Care |
| Usual surgical care (post-operative)This group will receive standard post-operative care. | Behavioural | Enhanced Usual Care then Usual Surgical Care, Preoperative Virtual Health Coaching then Usual Surgical Care |
| Postoperative Virtual Health CoachingPostoperative Virtual Coaching uses the same framework and structure as Preoperative Virtual Coaching. These sessions will be delivered by a health coach using a collaborative, and motivational interviewing-based approach. The goal of these sessions is to promote well-being and help participants maintain alcohol abstinence or reduction long-term (or initiate change in alcohol use if they have not already). These sessions promote low-risk alcohol use, provide education on chronic health effects of heavy alcohol use, and teach skills for coping with or avoiding triggers for alcohol use including coping with stress and mood challenges. These sessions introduce skills to help participants manage alcohol, stress, and mood as they recover from surgery. | Behavioural | Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track), Enhanced Usual Care then Post-operative Health Coaching, Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track), Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching |
| On-Track (Post-operative)On-Track is a mobile and web-accessible health tool that uses self-monitoring and provision of feedback on progress towards goals to engage participants in self-management of alcohol use and motivate behavior change through increased self-awareness and accountability for health. The On-Track application includes a) daily tracking of alcohol and other substance use; b) daily tracking of stress, mood, and pain; c) personalized health goals; and d) visual displays of alcohol use, stress, mood, pain, and goal achievement including graphs of trends over time. On-Track also uses novel monetary and non-monetary incentives to encourage utilization including an escalating monetary incentive schedule for self-monitoring. | Behavioural | Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track), Enhanced Usual Care then On-Track, Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track), Preoperative Virtual Health Coaching then On-Track |
Primary outcome
Alcohol consumption as measured by the timeline follow-back
Time frame: 10 months after surgical discharge
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.
2 secondary outcomes
World Health Organization Drinking (WHO) Risk Level
Time frame: 10 months after surgical discharge
Alcohol Use Disorder Identification test (AUDIT)
Time frame: Up to 10 months after surgical discharge
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 Aug 2026.
- Individual participant dataSharing planned: Yes. National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.
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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. This study is not recruiting at the moment.
Lara Coughlin, PhD principal investigator
University of Michigan
Anne Fernandez, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Virtual Health Coaching, Usual surgical care (post-operative) and Postoperative Virtual Health Coaching in people with Alcohol Drinking, run by University of Michigan at 1 site in United States.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption as measured by the timeline follow-back (time frame: 10 months after surgical discharge). 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 Aug 2026.