- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592978
Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain
November 20, 2023 updated by: Joseph W. Ditre, Syracuse University
Personalized Feedback Intervention to Address Hazardous Drinking and Alcohol-Opioid Interactions Among Adults With Chronic Pain.
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
195
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph W. Ditre, PhD
- Phone Number: 315-443-1052
- Email: jwditre@syr.edu
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Recruiting
- Syracuse University
-
Contact:
- Joseph W. Ditre
- Email: jwditre@syr.edu
-
Principal Investigator:
- Joseph W Ditre, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain-Alcohol Personalized Feedback 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
|
The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and immediately after receiving the intervention
|
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.
|
Baseline and immediately after receiving the intervention
|
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.
|
Baseline and immediately after receiving the intervention
|
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.
|
Baseline and immediately after receiving the intervention
|
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.
|
Baseline and 3 month follow-up
|
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.
|
Baseline and 3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2021
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 16, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA028639 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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