search
Back to results

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

Primary Purpose

Alcohol Drinking, Pain, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain-Alcohol Personalized Feeback Intervention
Control Personalized Feedback Intervention
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol, Opioids, Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Syracuse UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain-Alcohol Personalized Feedback Intervention

Control Personalized Feedback Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in knowledge of adverse pain-alcohol-opioid interrelations
Assessed via greater number of correct responses on the 10-item Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ).
Change in motivation/readiness to reduce drinking
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.
Change in attitudes and intentions to co-use alcohol and opioids
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.
Change in expectancies for pain-coping/reduction via drinking
Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater EAA scores (range: 0-45) indicate greater expectancies for alcohol analgesia.
Change in hazardous drinking
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.
Change in frequency of alcohol-opioid co-use
Assessed via self-reported number of days in which alcohol and prescription opioids were concurrently used in the past two weeks.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
June 21, 2022
Sponsor
Syracuse University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04592978
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Pain, Opioid Use, Feedback, Psychological
Keywords
Alcohol, Opioids, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain-Alcohol Personalized Feedback Intervention
Arm Type
Experimental
Arm Title
Control Personalized Feedback Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Pain-Alcohol Personalized Feeback Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Personalized Feedback Intervention
Intervention Description
The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.
Primary Outcome Measure Information:
Title
Change in knowledge of adverse pain-alcohol-opioid interrelations
Description
Assessed via greater number of correct responses on the 10-item Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ).
Time Frame
Baseline and immediately after receiving the intervention
Title
Change in motivation/readiness to reduce drinking
Description
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.
Time Frame
Baseline and immediately after receiving the intervention
Title
Change in attitudes and intentions to co-use alcohol and opioids
Description
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.
Time Frame
Baseline and immediately after receiving the intervention
Title
Change in expectancies for pain-coping/reduction via drinking
Description
Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater EAA scores (range: 0-45) indicate greater expectancies for alcohol analgesia.
Time Frame
Baseline and immediately after receiving the intervention
Title
Change in hazardous drinking
Description
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.
Time Frame
Baseline and 3 month follow-up
Title
Change in frequency of alcohol-opioid co-use
Description
Assessed via self-reported number of days in which alcohol and prescription opioids were concurrently used in the past two weeks.
Time Frame
Baseline and 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph W. Ditre, PhD
Phone
315-443-1052
Email
jwditre@syr.edu
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph W. Ditre
Email
jwditre@syr.edu
First Name & Middle Initial & Last Name & Degree
Joseph W Ditre, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs