Alcohol Use and Chronic Pain Among Primary Care Patients

Boston University Charles River Campus

Status: Completed

Conditions: Chronic Pain; Alcohol Drinking

Treatments: Behavioral: mhealth-pc for alcohol and pain; Behavioral: Treatment As Usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04958200

R34AA027598-01 (U.S. NIH Grant/Contract)

4947

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

mhealth-pc for alcohol and chronic pain

Experimental group

Description:

Smartphone-based intervention

Treatment:

Behavioral: mhealth-pc for alcohol and pain

Treatment As Usual

Active Comparator group

Description:

In person session that provides enhanced treatment as usual

Treatment:

Behavioral: Treatment As Usual