- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958200
Alcohol Use and Chronic Pain Among Primary Care Patients
April 1, 2023 updated by: Tibor Palfai, Boston University Charles River Campus
Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tibor Palfai, PhD
- Phone Number: 617-353-9345
- Email: palfai@bu.edu
Study Contact Backup
- Name: Maya Kratzer, BA
- Email: mkratzer@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Boston University Department of Psychological and Brain Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mhealth-pc for alcohol and chronic pain
Smartphone-based intervention
|
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
|
psychoeducation on pain and alcohol use and treatment resource information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Time Line Followback (30)- Heavy Drinking Episodes
Time Frame: Past 30 days
|
Number of heavy drinking episodes on a single occasion (5+ drinks men/4+ drinks women)
|
Past 30 days
|
Alcohol Time Line Followback (30)- Average Drinks per Week
Time Frame: Past 30 days
|
Average number of standard alcohol-containing drinks per week
|
Past 30 days
|
The Pain, Enjoyment of Life, General Activity (PEG) Scale
Time Frame: Past 7 days
|
Three items from the Brief Pain Inventory (BPI) to assess chronic pain.
Range 0-30.
Higher scores reflect worse outcomes
|
Past 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity - Brief Pain Inventory (BPI) items
Time Frame: 7 days
|
Four items from the BPI to assess chronic pain intensity.
Each item 0-10.
Higher scores reflect worse outcomes
|
7 days
|
Pain Interference
Time Frame: 7 days
|
Seven items from the BPI to assess chronic pain interference.
Each item is 0-10.
Higher scores reflect worse outcomes
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2021
Primary Completion (Actual)
March 28, 2023
Study Completion (Actual)
March 28, 2023
Study Registration Dates
First Submitted
June 30, 2021
First Submitted That Met QC Criteria
June 30, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 1, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4947 (HSØ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data sharing procedures that will be implemented within one year of completion of the study.
Specific data may be shared based on proposals received and reviewed by the study investigators and limited public-use data sets might be prepared and made available.
In either case, data will be shared only after all planned reports of study findings have been prepared.
Data to be shared will be de-identified to minimize the risk of deductive disclosure.
Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation.
Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
IPD Sharing Time Frame
Data will be available after all planned reports of study findings have been prepared within one year of project completion.
Data will be available upon request for 5 years following these reports
IPD Sharing Access Criteria
Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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