Clinical trial NCT04592978: Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain
Official title: Personalized Feedback Intervention to Address Hazardous Drinking and Alcohol-Opioid Interactions Among Adults With Chronic Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Pain
Opioid Use
Feedback, Psychological
Keywords: Alcohol
Opioids
Pain
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-10-19
Enrollment: 195
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in knowledge of adverse pain-alcohol-opioid interrelations
timeFrame: Baseline and immediately after receiving the intervention
measure: Change in motivation/readiness to reduce drinking
timeFrame: Baseline and immediately after receiving the intervention
measure: Change in attitudes and intentions to co-use alcohol and opioids
timeFrame: Baseline and immediately after receiving the intervention
measure: Change in expectancies for pain-coping/reduction via drinking
timeFrame: Baseline and immediately after receiving the intervention
measure: Change in hazardous drinking
timeFrame: Baseline and 3 month follow-up
measure: Change in frequency of alcohol-opioid co-use
timeFrame: Baseline and 3 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References: