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

NCT04592978 | Completed Results DMC

• 1 other identifier: R01AA028639
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Drinking; Pain; Opioid Use; Feedback, Psychological

Keywords

Alcohol; Opioids; Pain

Outcome Measures

Primary Outcomes (6)

• Knowledge of Adverse Pain-alcohol-opioid Interrelations

  Assessed via number of correct responses on the Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ). Scores ranged from 0-7, with higher scores indicating more correct responses.

  Immediately after receiving the intervention, within a single 90-minute study session.

• Motivation/Readiness to Reduce Drinking

  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.

  Immediately after receiving the intervention, within a single 90-minute study session.

• Attitudes and Intentions to Co-use Alcohol and Opioids

  Assessed via the 6-item Intention to Co-Use Alcohol and Opioids Scale (range: 6-42), with higher scores indicating greater intention to co-use alcohol and opioids, and via the 14-item alcohol-opioid co-use attitudes scale (range: 14-78), with greater scores indicating more positive attitudes about alcohol-opioid co-use.

  Immediately after receiving the intervention, within a single 90-minute study session.

• Expectancies for Pain-coping/Reduction Via Drinking

  Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater scores (range: 0-45) indicate greater expectations that alcohol will reduce pain.

  Immediately after receiving the intervention, within a single 90-minute study session.

• Hazardous Drinking

  Assessed via scores on Alcohol Use Disorders Identification Test - Consumption Sub-Score (AUDIT-C), where scores greater than or equal to 4 for males and 3 for females indicate the presence of hazardous alcohol consumption. Table indicates the number and percentage of participants who reported no hazardous consumption (row 1) or hazardous consumption (row 2) at follow-up.

  Three-month follow-up

• Frequency of Alcohol-opioid Co-use

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

  Three-month follow-up

Study Arms (2)

Pain-Alcohol Personalized Feedback Intervention

EXPERIMENTAL

Behavioral: Pain-Alcohol Personalized Feeback Intervention

Control Personalized Feedback Intervention

ACTIVE COMPARATOR

Behavioral: Control Personalized Feedback Intervention

Interventions

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.

Pain-Alcohol Personalized Feedback Intervention

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.

Control Personalized Feedback Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Syracuse University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Joseph Ditre
• Organization: Syracuse University

jwditre@syr.edu

315.443.4792

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stage 1A will consist of 3 focus groups of 7 individuals used to develop and refine the pain-alcohol personalized feedback intervention (PFI). Stage 1B will employ a randomized controlled trial to compare the effects of the pain-alcohol PFI to a control PFI.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: July 30, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 11, 2026
• Results First Posted: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)