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Alcohol Use and Chronic Pain Among Primary Care Patients
NA trial testing mhealth-pc for alcohol and pain in Alcohol Drinking in 49 participants. Completed in 28 March 2023.
| Lead sponsor | Boston University Charles River Campus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 26 August 2021 |
| Primary completion | 28 March 2023 |
| Estimated completion | 28 March 2023 |
| Sites | 1 location across United States |
Boston University Charles River Campus
18 and older, any sex, with Alcohol Drinking or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)
| Group | Value | 95% CI |
|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | 7.9 | ± 11.32 |
| Treatment As Usual | 4.3 | ± 5.57 |
Average number of standard alcohol-containing drinks per week over the past 30 days
| Group | Value | 95% CI |
|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | 16.89 | ± 20.60 |
| Treatment As Usual | 10.56 | ± 9.02 |
Three items which assess chronic pain intensity and interference. Range of each item is 0-10. Mean rating of the three items indicate the PEG pain score. range of scale is 0-10. Higher scores reflect worse outcomes
| Group | Value | 95% CI |
|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | 4.60 | ± 2.56 |
| Treatment As Usual | 4.82 | ± 1.79 |
Four items from the Brief Pain Inventory (BPI) comprise the pain severity subscale. Pain severity score reflects the mean item rating of these 4 items. Range 0-10. Higher scores reflect worse outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | 3.98 | ± 1.93 |
| Treatment As Usual | 4.16 | ± 1.21 |
Seven items from the BPI are used to assess chronic pain interference. Each item is 0-10. The pain interference score is the mean of these seven items and ranges from 0-10. Higher scores reflect worse outcomes
| Group | Value | 95% CI |
|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | 4.37 | ± 2.63 |
| Treatment As Usual | 4.68 | ± 2.36 |
Time frame: Adverse events were collected throughout the period in which the participant was in the study which was 16-weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mhealth-pc for Alcohol and… | Treatment As Usual |
|---|---|---|---|
| Hospitalization | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Mhealth-pc for Alcohol and… | Treatment As Usual |
|---|---|---|---|
| hospital visit for uncontrolled diabetes | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Hospitalization.
Data from ClinicalTrials.gov NCT04958200 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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