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Completed

NCT Number: NCT04958200

Alcohol Use and Chronic Pain Among Primary Care Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Department of Psychological and Brain Sciences

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mhealth-pc for alcohol and pain

Behavioral

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

Treatment as Usual

Behavioral

psychoeducation on pain and alcohol use and treatment resource information

Primary outcomes

  1. Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days

    Time frame: 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)

  2. Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days

    Time frame: Past 30 days as assessed at the 16-week timepoint

    Average number of standard alcohol-containing drinks per week over the past 30 days

  3. The Pain, Enjoyment of Life, General Activity (PEG) Scale

    Time frame: 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 outcomes

  1. Pain Intensity - Brief Pain Inventory (BPI) Items

    Time frame: 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.

  2. Pain Interference

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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