Alcohol Use and Chronic Pain Among Primary Care Patients

Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Chronic Pain
• Intervention / Treatment: Behavioral: mhealth-pc for alcohol and pain; Behavioral: Treatment As Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University Department of Psychological and Brain Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mhealth-pc for alcohol and chronic pain; Smartphone-based intervention	Behavioral: mhealth-pc for alcohol and pain; Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
Active Comparator: Treatment As Usual; In person session that provides enhanced treatment as usual	Behavioral: Treatment As Usual; psychoeducation on pain and alcohol use and treatment resource information

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity - Brief Pain Inventory (BPI) Items	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.	past 7 days as assessed at the 16-week timepoint
Pain Interference	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	past 7 days as assessed at the 16-week timepoint

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Drinking Behavior; Alcohol Drinking; Chronic Pain
• Other Study ID Numbers: 4947 (HSØ); R34AA027598-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing procedures that will be implemented within one year of completion of the study. Specific data may be shared based on proposals received and reviewed by the study investigators and limited public-use data sets might be prepared and made available. In either case, data will be shared only after all planned reports of study findings have been prepared. Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
• IPD Sharing Time Frame: Data will be available after all planned reports of study findings have been prepared within one year of project completion. Data will be available upon request for 5 years following these reports
• IPD Sharing Access Criteria: Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No