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

Syracuse University

Status: Enrolling

Conditions: Feedback, Psychological; Opioid Use; Pain; Alcohol Drinking

Treatments: Behavioral: Pain-Alcohol Personalized Feeback Intervention; Behavioral: Control Personalized Feedback Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04592978

R01AA028639 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 195 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 2 patient groups

Pain-Alcohol Personalized Feedback Intervention

Experimental group

Treatment:

Behavioral: Pain-Alcohol Personalized Feeback Intervention

Control Personalized Feedback Intervention

Active Comparator group

Treatment:

Behavioral: Control Personalized Feedback Intervention