Alcohol DrinkingNCT04592978
Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain
A study testing Pain-Alcohol Personalized Feeback Intervention in people with Alcohol Drinking and Pain, run by Syracuse University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Drinking, Pain, Opioid Use
- What is being tested?
- Pain-Alcohol Personalized Feeback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 21 years of age
- Current hazardous drinker
- Current chronic pain
- Current use of prescription opioid medications.
Who cannot join
- Current alcohol or other substance use treatment
- Not being fluent in English
- Current psychiatric distress or thought disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Drinking, Pain, Opioid Use, Feedback, Psychological
- Being tested
- Pain-Alcohol Personalized Feeback Intervention, Control Personalized Feedback Intervention
- Keywords
- Alcohol, Opioids, Pain
- Medical subject headings
- Alcohol Drinking, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain-Alcohol Personalized Feeback InterventionBehavioural
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.
Control Personalized Feedback InterventionBehavioural
The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.
| Study group | Role | What they receive |
|---|---|---|
| Pain-Alcohol Personalized Feedback Intervention | Experimental | Not described Receives: Behavioral: Pain-Alcohol Personalized Feeback Intervention |
| Control Personalized Feedback Intervention | Active comparator | Not described Receives: Behavioral: Control Personalized Feedback Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Adverse Pain-alcohol-opioid Interrelations
Assessed via number of correct responses on the Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ). Scores ranged from 0-7, with higher scores indicating more correct responses.
Measured: Immediately after receiving the intervention, within a single 90-minute study session.
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.
Measured: Immediately after receiving the intervention, within a single 90-minute study session.
Attitudes and Intentions to Co-use Alcohol and Opioids
Assessed via the 6-item Intention to Co-Use Alcohol and Opioids Scale (range: 6-42), with higher scores indicating greater intention to co-use alcohol and opioids, and via the 14-item alcohol-opioid co-use attitudes scale (range: 14-78), with greater scores indicating more positive attitudes about alcohol-opioid co-use.
Measured: Immediately after receiving the intervention, within a single 90-minute study session.
Expectancies for Pain-coping/Reduction Via Drinking
Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater scores (range: 0-45) indicate greater expectations that alcohol will reduce pain.
Measured: Immediately after receiving the intervention, within a single 90-minute study session.
Hazardous Drinking
Assessed via scores on Alcohol Use Disorders Identification Test - Consumption Sub-Score (AUDIT-C), where scores greater than or equal to 4 for males and 3 for females indicate the presence of hazardous alcohol consumption.
Table indicates the number and percentage of participants who reported no hazardous consumption (row 1) or hazardous consumption (row 2) at follow-up.
Measured: Three-month follow-up
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.
Measured: Three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start30 Jul 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Joseph W. Ditre, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592978
- Sponsor's protocol ID
- R01AA028639
- Other IDs
- R01AA028639
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2020
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Feedback Intervention to Address Hazardous Drinking and Alcohol-Opioid Interactions Among Adults With Chronic Pain.
- ClinicalTrials.gov ID
- NCT04592978
- Acronym / sponsor ID
- R01AA028639
- Conditions
- Alcohol Drinking, Pain, Opioid Use, Feedback, Psychological
- Keywords
- Alcohol, Opioids, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pain-Alcohol Personalized Feedback Intervention | Experimental | Behavioral: Pain-Alcohol Personalized Feeback Intervention |
| Control Personalized Feedback Intervention | Active comparator | Behavioral: Control Personalized Feedback Intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 21 years of age
- Current hazardous drinker
- Current chronic pain
- Current use of prescription opioid medications.
Key exclusion criteria (3 listed)
- Current alcohol or other substance use treatment
- Not being fluent in English
- Current psychiatric distress or thought disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain-Alcohol Personalized Feeback InterventionThe 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. | Behavioural | Pain-Alcohol Personalized Feedback Intervention |
| Control Personalized Feedback InterventionThe control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations. | Behavioural | Control Personalized Feedback Intervention |
Primary outcome
Knowledge of Adverse Pain-alcohol-opioid Interrelations
Time frame: Immediately after receiving the intervention, within a single 90-minute study session.
Assessed via number of correct responses on the Pain Alcohol Opioid Knowledge Questionnaire (PAOKQ). Scores ranged from 0-7, with higher scores indicating more correct responses.
Motivation/Readiness to Reduce Drinking
Time frame: Immediately after receiving the intervention, within a single 90-minute study session.
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.
Attitudes and Intentions to Co-use Alcohol and Opioids
Time frame: Immediately after receiving the intervention, within a single 90-minute study session.
Assessed via the 6-item Intention to Co-Use Alcohol and Opioids Scale (range: 6-42), with higher scores indicating greater intention to co-use alcohol and opioids, and via the 14-item alcohol-opioid co-use attitudes scale (range: 14-78), with greater scores indicating more positive attitudes about alcohol-opioid co-use.
Expectancies for Pain-coping/Reduction Via Drinking
Time frame: Immediately after receiving the intervention, within a single 90-minute study session.
Assessed via Expectancies for Alcohol Analgesia (EAA) measure, where greater scores (range: 0-45) indicate greater expectations that alcohol will reduce pain.
Hazardous Drinking
Time frame: Three-month follow-up
Assessed via scores on Alcohol Use Disorders Identification Test - Consumption Sub-Score (AUDIT-C), where scores greater than or equal to 4 for males and 3 for females indicate the presence of hazardous alcohol consumption. Table indicates the number and percentage of participants who reported no hazardous consumption (row 1) or hazardous consumption (row 2) at follow-up.
Frequency of Alcohol-opioid Co-use
Time frame: Three-month follow-up
Assessed via self-reported number of days in which alcohol and prescription opioids were concurrently used in the past two weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain-Alcohol Personalized Feeback Intervention in people with Alcohol Drinking and Pain, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Adverse Pain-alcohol-opioid Interrelations (time frame: Immediately after receiving the intervention, within a single 90-minute study session.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.