Personalized Feedback for Chronic Pain with Substance Use
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it focuses on people who are currently prescribed opioids, so it seems likely that you can continue taking them.
What data supports the effectiveness of the treatment Personalized Feedback Intervention for chronic pain with substance use?
Is the Personalized Feedback Intervention safe for humans?
The research suggests that personalized feedback interventions, which are often computer-based, are generally safe and can help improve pain outcomes and reduce problematic alcohol consumption. However, specific safety data for this intervention in humans is not detailed in the available studies.12678
How is the Pain-Alcohol Personalized Feedback Intervention treatment different from other treatments for chronic pain with substance use?
The Pain-Alcohol Personalized Feedback Intervention is unique because it uses personalized feedback to motivate behavior change by providing tailored and normative feedback, which can improve pain outcomes and reduce problematic alcohol consumption. This approach is computer-based, making it accessible and reducing the burden on both patients and healthcare providers.125910
Research Team
Eligibility Criteria
This trial is for adults over 21 with chronic pain who drink alcohol hazardously and are currently using prescription opioids. It's not for those who don't speak English, have severe mental health issues, or are already in treatment for substance use.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase IA - Intervention Development
Collecting qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility
Phase IB - Randomized Clinical Trial
Proof-of-concept trial comparing PA-PFI to control PFI among hazardous drinkers with chronic pain
Follow-up
Participants are monitored for changes in alcohol-opioid co-use, motivation to reduce drinking, and other outcomes
Treatment Details
Interventions
- Control Personalized Feedback Intervention (Behavioural Intervention)
- Pain-Alcohol Personalized Feedback Intervention (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syracuse University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator