N/A
N=48
Alcohol Use and Chronic Pain Among Primary Care Patients
Alcohol Drinking · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04958200 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Dec 2024
Primary outcome: Primary: Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days — 7.9; 4.3 heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mhealth-pc for alcohol and pain (Behavioral); Treatment As Usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days |
7.9; 4.3 | — |
| PRIMARY Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days |
16.89; 10.56 | — |
| PRIMARY The Pain, Enjoyment of Life, General Activity (PEG) Scale |
4.60; 4.82 | — |
| SECONDARY Pain Intensity - Brief Pain Inventory (BPI) Items |
3.98; 4.16 | — |
| SECONDARY Pain Interference |
4.37; 4.68 | — |
Summary
Chronic pain and unhealthy drinking are common co-occurring conditions among patients presenting to primary care. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce unhealthy alcohol use and pain that can be readily incorporated into the primary care setting. The objective of this study is to test a smartphone-based intervention for reducing unhealthy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on drinking and chronic pain outcomes.
Eligibility Criteria
Inclusion Criteria
- 1 heavy drinking: defined as either [1] an average of more than 7(for women)/14 (for men) standard drinks per week over the past month or [2] one or more heavy drinking episodes (4+ standard drinks for women, 5+ standard drinks for men)
- 2 chronic pain: defined as non-cancer related pain of at least 3 months duration rated as moderate or greater (past week pain severity rating of 4 or greater on the BPI severity item)
Exclusion Criteria
- psychoactive medication for pain or alcohol use for fewer than 2 months
- history of bipolar disorder or schizophenia
- current expressed suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- behavioral treatment for pain or alcohol use in the past 3 months
- any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Data sourced from ClinicalTrials.gov (NCT04958200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.