Alcohol Use and Chronic Pain Among Primary Care Patients

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04958200
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mhealth-pc for alcohol and pain
  • Behavioral: Treatment As Usual
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Compare intervention to a treatment as usual comparison conditionCompare intervention to a treatment as usual comparison condition
Masking:
Single (Outcomes Assessor)
Masking Description:
Eight-week and 16-week assessments will be completed by assessor who is masked to intervention condition. Baseline assessment takes place before randomization
Primary Purpose:
Treatment
Official Title:
Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care
Actual Study Start Date :
Aug 26, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Alcohol Time Line Followback (30)- Heavy Drinking Episodes [Past 30 days]

    Number of heavy drinking episodes on a single occasion (5+ drinks men/4+ drinks women)

  2. Alcohol Time Line Followback (30)- Average Drinks per Week [Past 30 days]

    Average number of standard alcohol-containing drinks per week

  3. The Pain, Enjoyment of Life, General Activity (PEG) Scale [Past 7 days]

    Three items from the Brief Pain Inventory (BPI) to assess chronic pain. Range 0-30. Higher scores reflect worse outcomes

Secondary Outcome Measures

  1. Pain Intensity - Brief Pain Inventory (BPI) items [7 days]

    Four items from the BPI to assess chronic pain intensity. Each item 0-10. Higher scores reflect worse outcomes

  2. Pain Interference [7 days]

    Seven items from the BPI to assess chronic pain interference. Each item is 0-10. Higher scores reflect worse outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston University Department of Psychological and Brain Sciences Boston Massachusetts United States 02215

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tibor Palfai, Professor of Psychological and Brain Sciences, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT04958200
Other Study ID Numbers:
  • 4947
First Posted:
Jul 12, 2021
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2021