Alcohol Drinking, Feedback, Psychological, Opioid Use, Pain
Conditions
Keywords
Alcohol, Opioids, Pain
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.
Interventions
BEHAVIORALPain-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.
The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.
Sponsors
Syracuse University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Adverse Pain-alcohol-opioid Interrelations | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Phase 1A: 23 enrolled for qualitative intervention development; 21 completed the intervention and contributed usable development data. Phase 1B: 183 enrolled; 8 determined ineligible prior to randomization; 175 randomized to Integrated PFI or Control PFI; 173 completed the intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Adverse pain-alcohol-opioid interrelations | 3.52 Number of Correct Responses STANDARD_DEVIATION 2.287 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants |
| Attitudes and intentions to co-use alcohol and opioids Alcohol-Opioid Co-Use Attitudes Scale | 48.444 Units on a scale STANDARD_DEVIATION 12.323 |
| Attitudes and intentions to co-use alcohol and opioids Intention to Co-Use Alcohol and Opioids Scale | 21.62 Units on a scale STANDARD_DEVIATION 10.985 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Expectancies for pain-coping/reduction via drinking | 24.32 Units on a scale STANDARD_DEVIATION 13.568 |
| Frequency of alcohol-opioid co-use Same Day Co-Use | 5.19 Days STANDARD_DEVIATION 4.618 |
| Frequency of alcohol-opioid co-use Within 2 Hours Co-Use | 4.62 Days STANDARD_DEVIATION 4.72 |
| Hazardous Drinking Hazardous Consumption | 194 Participants |
| Hazardous Drinking No Hazardous Consumption | 0 Participants |
| Motivation/readiness to reduce drinking | 6.44 Units on a scale STANDARD_DEVIATION 2.666 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 194 Participants |
| Sex/Gender, Customized Gender Identity Man | 13 Participants |
| Sex/Gender, Customized Gender Identity Woman | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 90 | 0 / 85 |
| other Total, other adverse events | 0 / 21 | 0 / 90 | 0 / 85 |
| serious Total, serious adverse events | 0 / 21 | 0 / 90 | 0 / 85 |
Outcome results
None listed