Alcohol Use and Chronic Pain Among Primary Care Patients

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958200
• Other study ID #: 4947
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2023
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Chronic Pain

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.
• Treatment As Usual
psychoeducation on pain and alcohol use and treatment resource information

Locations

Country	Name	City	State
United States	Boston University Department of Psychological and Brain Sciences	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Time Line Followback (30)- Heavy Drinking Episodes	Number of heavy drinking episodes on a single occasion (5+ drinks men/4+ drinks women)	Past 30 days
Primary	Alcohol Time Line Followback (30)- Average Drinks per Week	Average number of standard alcohol-containing drinks per week	Past 30 days
Primary	The Pain, Enjoyment of Life, General Activity (PEG) Scale	Three items from the Brief Pain Inventory (BPI) to assess chronic pain. Range 0-30. Higher scores reflect worse outcomes	Past 7 days
Secondary	Pain Intensity - Brief Pain Inventory (BPI) items	Four items from the BPI to assess chronic pain intensity. Each item 0-10. Higher scores reflect worse outcomes	7 days
Secondary	Pain Interference	Seven items from the BPI to assess chronic pain interference. Each item is 0-10. Higher scores reflect worse outcomes	7 days