Alcohol Use and Chronic Pain Among Primary Care Patients

Not Applicable

Completed

Conditions: Alcohol Drinking
Chronic Pain

Registration Number: NCT04958200

Lead Sponsor: Boston University Charles River Campus

Brief 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.

Detailed Description: Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use in primary care is often a challenge as patients typically present with co-morbid conditions that: (1) may make unhealthy drinking a lower priority health issue and (2) may impact the capacity for sustained alcohol-related change. Chronic pain is among the most common of these conditions among primary care patients. Pain is a frequent source of distress and disability among primary care patients and is one of the most frequent causes for visits. Pain is also an important trigger for alcohol use among primary care patients who drink and is associated with the experience of negative alcohol-related consequences and unhealthy drinking over time. The experience of pain has also been shown to be associated with poorer responses to alcohol interventions. Primary care physicians face a number of challenges when attempting to treat co-occurring unhealthy drinking and pain among their patients. Pain management and reduction of alcohol use among those who engage in heavy alcohol use is often not adequately achieved with pharmacological treatments nor are pharmacological treatments indicated for common pain conditions. Moreover, despite the availability of evidence-based psychosocial interventions for unhealthy drinking and chronic pain, patients with each of these conditions typically show poor adherence to treatment. Given the rates of pain and unhealthy alcohol use among primary care patients and their impact on functioning and medical outcomes, there would be considerable benefit to an accessible, easily utilized, integrative approach to treat heavy alcohol use and pain that can be readily incorporated into the primary care setting. The objectives of this study are to develop a smartphone-based intervention for reducing heavy 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 outcomes, and develop procedures to conduct a Stage II efficacy trial.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days	Past 30 days as assessed at the 16-week timepoint	Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)
Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days	Past 30 days as assessed at the 16-week timepoint	Average number of standard alcohol-containing drinks per week over the past 30 days
The Pain, Enjoyment of Life, General Activity (PEG) Scale	Past 7 days as assessed at the 16-week timepoint	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

Secondary Outcome Measures

Name	Time	Method
Pain Intensity - Brief Pain Inventory (BPI) Items	past 7 days as assessed at the 16-week timepoint	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.
Pain Interference	past 7 days as assessed at the 16-week timepoint	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

Trial Locations

Locations (1): Boston University Department of Psychological and Brain Sciences
🇺🇸
Boston, Massachusetts, United States
Boston University Department of Psychological and Brain Sciences
🇺🇸Boston, Massachusetts, United States