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Completed

NCT Number: NCT04592978

Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain

Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. This intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain, hazardous drinking, and concurrent alcohol-prescription opioid use, we believe the current study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol-opioid relations, and inform the development of novel treatments for hazardous drinkers with chronic pain that are adaptable and easily implemented across a variety of healthcare settings.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Feedback, Psychological Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse University

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 21 years of age
  • Current hazardous drinker
  • Current chronic pain
  • Current use of prescription opioid medications.

Exclusion criteria

  • Current alcohol or other substance use treatment
  • Not being fluent in English
  • Current psychiatric distress or thought disorder.

Treatment and study plan

Pain-Alcohol Personalized Feeback Intervention

Behavioral

The intervention will be designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations as well as increase motivation and intention to reduce hazardous drinking and positive attitudes and intentions regarding concurrent use of alcohol and prescription opioid medications.

Control Personalized Feedback Intervention

Behavioral

The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.

Primary outcomes

  1. Change in knowledge of adverse pain-alcohol-opioid interrelations

    Time frame: Baseline and immediately after receiving the intervention

    Assessed via greater number of correct responses on the 10-item Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ).

  2. Change in motivation/readiness to reduce drinking

    Time frame: Baseline and immediately after receiving the intervention

    Assessed via Alcohol Ladder: a visual analogue contemplation ladder providing a single continuous metric of motivation and readiness to reduce drinking, where higher responses (range: 1-10) indicating greater motivation/readiness to change/reduce drinking.

  3. Change in attitudes and intentions to co-use alcohol and opioids

    Time frame: Baseline and immediately after receiving the intervention

    Assessed via Alcohol-Opioid Co-Use Attitudes/Intentions (AOAI) measure, where greater scores (range: 16-62) indicate more positive attitudes and greater intentions to co-use alcohol and opioids.

  4. Change in expectancies for pain-coping/reduction via drinking

    Time frame: Baseline and immediately after receiving the intervention

    Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater EAA scores (range: 0-45) indicate greater expectancies for alcohol analgesia.

  5. Change in hazardous drinking

    Time frame: Baseline and 3 month follow-up

    Assessed via scores on Alcohol Use Disorders Identification Test (AUDIT), where scores greater than or equal to 8 for males and 7 for females indicate the presence of hazardous drinking.

  6. Change in frequency of alcohol-opioid co-use

    Time frame: Baseline and 3 month follow-up

    Assessed via self-reported number of days in which alcohol and prescription opioids were concurrently used in the past two weeks.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Personalized Feedback Intervention to Address Hazardous Drinking and Alcohol-Opioid Interactions Among Adults With Chronic Pain.

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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