Alcohol Use and Chronic Pain Among Primary Care Patients

NCT ID: NCT04958200

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2023-03-28

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.

Conditions

Alcohol Drinking; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

mhealth-pc for alcohol and chronic pain

Smartphone-based intervention

Group Type: EXPERIMENTAL

mhealth-pc for alcohol and pain

Intervention Type: BEHAVIORAL

Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.

Treatment As Usual

In person session that provides enhanced treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: BEHAVIORAL

psychoeducation on pain and alcohol use and treatment resource information

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment As Usual

psychoeducation on pain and alcohol use and treatment resource information

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Tibor Palfai

Professor of Psychological and Brain Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston University Department of Psychological and Brain Sciences

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AA027598-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4947

Identifier Type: -

Identifier Source: org_study_id