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Active, not recruitingNCT05783635ASPIRE-2Updated Aug 10, 2026

Alcohol Screening and Preoperative Intervention Research Study - 2

An interventional study of Enhanced Usual Care (pre-operative) and Preoperative Virtual Health Coaching in Alcohol Drinking, sponsored by University of Michigan. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Drinking

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Keywords

  • Surgery
03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's planned enrollment of 440 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Completed consent form, baseline survey, and enrollment phone call
  2. Willingness to comply with all study procedures and availability for the duration of the study
  3. Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
  4. Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
  5. Access to a smart device or computer access with internet or wi-fi connection throughout the study period

Exclusion criteria

Exclusion Criteria:

  1. Exclude participants enrolled in another research study focused on alcohol use
  2. History of severe alcohol withdrawal
  3. Unable to speak, understand, or read English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Enhanced Usual Care then Usual Surgical Care

    Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

    Behavioral: Enhanced Usual Care (pre-operative) · Behavioral: Usual surgical care (post-operative)

  • Experimental
    Enhanced Usual Care then Post-operative Health Coaching

    Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

    Behavioral: Enhanced Usual Care (pre-operative) · Behavioral: Postoperative Virtual Health Coaching

  • Experimental
    Enhanced Usual Care then On-Track

    Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

    Behavioral: Enhanced Usual Care (pre-operative) · Behavioral: On-Track (Post-operative)

  • Experimental
    Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)

    Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

    Behavioral: Enhanced Usual Care (pre-operative) · Behavioral: Postoperative Virtual Health Coaching · Behavioral: On-Track (Post-operative)

  • Other
    Enhanced Usual Care alone

    Only completed first randomization. Study withdrawal prior to re-randomization

    Behavioral: Enhanced Usual Care (pre-operative)

  • Experimental
    Preoperative Virtual Health Coaching then Usual Surgical Care

    Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

    Behavioral: Preoperative Virtual Health Coaching · Behavioral: Usual surgical care (post-operative)

  • Experimental
    Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching

    Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

    Behavioral: Preoperative Virtual Health Coaching · Behavioral: Postoperative Virtual Health Coaching

  • Experimental
    Preoperative Virtual Health Coaching then On-Track

    Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

    Behavioral: Preoperative Virtual Health Coaching · Behavioral: On-Track (Post-operative)

  • Experimental
    Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)

    Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

    Behavioral: Preoperative Virtual Health Coaching · Behavioral: Postoperative Virtual Health Coaching · Behavioral: On-Track (Post-operative)

  • Other
    Preoperative Virtual Health Coaching only

    Only completed first randomization. Study withdrawal prior to re-randomization.

    Behavioral: Preoperative Virtual Health Coaching

Interventions

  • BehavioralEnhanced 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.

  • BehavioralPreoperative Virtual Health Coaching

    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.

  • BehavioralUsual surgical care (post-operative)

    This group will receive standard post-operative care.

  • BehavioralPostoperative Virtual Health Coaching

    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.

  • BehavioralOn-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 months after surgical discharge

Secondary outcomes

  1. 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).

    Time frame: 10 months after surgical discharge

  2. 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.

    Time frame: Up to 10 months after surgical discharge

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05783635
Lead sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Lara Coughlin (Associate Professor of Psychiatry, University of Michigan) — Principal investigator
First posted
Mar 24, 2023
Start date
Apr 17, 2023
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Lara Coughlin, PhD
principal investigator · University of Michigan
Anne Fernandez, PhD
principal investigator · Rutgers University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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