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

• ClinicalTrials.gov Identifier: NCT04592978
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: September 9, 2021
• Sponsor: Syracuse University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Joseph W. Ditre, Syracuse University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Drinking; Pain; Opioid Use; Feedback, Psychological	Behavioral: Pain-Alcohol Personalized Feeback Intervention; Behavioral: Control Personalized Feedback Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Personalized Feedback Intervention to Address Hazardous Drinking and Alcohol-Opioid Interactions Among Adults With Chronic Pain.
• Actual Study Start Date: August 26, 2021
• Estimated Primary Completion Date: May 31, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pain-Alcohol Personalized Feedback Intervention	Behavioral: Pain-Alcohol Personalized Feeback Intervention; 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.
Active Comparator: Control Personalized Feedback Intervention	Behavioral: Control Personalized Feedback Intervention; The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Joseph W. Ditre, PhD; 315-443-1052; jwditre@syr.edu

Locations

United States, New York

Syracuse University; Recruiting

Syracuse, New York, United States, 13210

Contact: Joseph W. Ditre jwditre@syr.edu

Principal Investigator: Joseph W Ditre, PhD

Sponsors and Collaborators

Syracuse University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

• Responsible Party: Joseph W. Ditre, Professor, Syracuse University
• ClinicalTrials.gov Identifier: NCT04592978
• Other Study ID Numbers: R01AA028639 ( U.S. NIH Grant/Contract ); R01AA028639 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2020
• Last Update Posted: September 9, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph W. Ditre, Syracuse University:

Alcohol; Opioids; Pain

Additional relevant MeSH terms:

Chronic Pain; Alcohol Drinking; Pain; Neurologic Manifestations; Drinking Behavior