Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study (NCT06281821) | Clinical Trial Compass
CompletedNot Applicable
Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study
United States32 participantsStarted 2024-02-06
Plain-language summary
Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 1 Heavy drinking by NIAAA guidelines (weekly limits \[\> 7 standard drinks for women or men age 65+, \> 14 for men younger than 65\], and/or a heavy drinking episode in the past month \[\>3 for women or men age 65+, \> 4 for men younger than 65\]) or by a positive USAUDIT-C score
* 2 Chronic pain \[at least 3 months in duration\] of at least moderate severity (4 or greater on the Numerical Pain Rating Scale from 0-10)
Exclusion Criteria:
* 1 If on medication for pain or alcohol, not on same dose for at least 2 months \[Note: Participants who are on psychoactive medications for pain management may be included if they have a stable (at least 2 months) medication dose and state a willingness to continue use of medication as prescribed by their physician through the intervention phase\]
* 2 Patients with bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent.
* 3 Prior history of withdrawal-related seizures or delirium tremens
* 4 Current non-pharmacological treatment for alcohol use disorder or chronic pain.
* 5 Any acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months
* 6 Pain that is related to a current cancer diagnosis
* 7 Patients who are unable to provide one or more individuals who will likely know where they are at follow up
* 8 Individuals who do not have a smartphone with which they can use to complete the remote study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale