Alcohol DrinkingNCT06281821
Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study
A study testing mhealth-pc in people with Alcohol Drinking and Chronic Pain, run by Boston University Charles River Campus at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Chronic Pain
- What is being tested?
- mhealth-pc
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol Use and Chronic Pain in Primary Care
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.
Read the detailed description
Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use is often a challenge as patients typically present to health care settings 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. Pain is a frequent source of distress and disability and is one of the most frequent causes for health care visits. Pain is also an important trigger for alcohol use among 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. There are 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 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 health care settings. The objectives of this study are to test the acceptability and feasibility of a smartphone-based intervention for reducing pain and alcohol use among individuals who experience chronic pain and heavy drinking. In addition, the study will provide a preliminary effect size estimates of the intervention on outcomes.
- Conditions
- Alcohol Drinking, Chronic Pain
- Being tested
- mhealth-pc
- Medical subject headings
- Alcohol Drinking, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhealth-pcBehavioural
Participants meet with an interventionist who explains the rationale for the mobile app. They complete video and survey-based intervention content each week for 8 weeks. App-based sessions are supplemented with brief chat-based coaching weekly.
| Study group | Role | What they receive |
|---|---|---|
| Mobile App Intervention | Experimental | Mobile health intervention delivered through an app Receives: Behavioral: mhealth-pc |
| Control | No intervention | Assessment Only Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale
Three items with 0-10 scales to assess chronic pain based on the dimensions of pain severity, impact on enjoyment in life, and interference with activity. Range 0-30. Higher scores reflect worse outcomes
Measured: 7-days
Time Line Follow-Back-30 Day Weekly Drinking
Average number of drinks per week over the past 30 days. Higher scores reflect worse outcomes.
Measured: past 30 days
Secondary outcomes (3)
Time Line Follow-Back 30-Day Heavy Episodic Drinking
number of heavy drinking episodes (for men 5 or more on single occasion for women 4+) over tha past 30 days. Higher values reflect worse outcomes
Measured: past 30 days
Perceptions of Treatment Questionnaire
Ratings of intervention satisfaction using Likert-scale items 0 "not at all" to 8 "very much" to assess degree of perceived help with pain and alcohol use, perceived helpfulness of intervention components. Higher scores reflect better outcomes
Measured: Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)
Systems Usability Scale
Three item Likert scale (scored 1 "strongly disagree' to 5 "strongly agree') to assess ease, speed of learning, confidence using the mobile app. Higher scores reflect better outcomes
Measured: Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start6 Feb 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare an intervention to an assessment only control condition
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tibor Palfai, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281821
- Sponsor's protocol ID
- 4947 [Study 2]
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Use and Chronic Pain in Primary Care
- ClinicalTrials.gov ID
- NCT06281821
- Acronym / sponsor ID
- 4947 [Study 2]
- Conditions
- Alcohol Drinking, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use is often a challenge as patients typically present to health care settings 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. Pain is a frequent source of distress and disability and is one of the most frequent causes for health care visits. Pain is also an important trigger for alcohol use among 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. There are 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 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 health care settings. The objectives of this study are to test the acceptability and feasibility of a smartphone-based intervention for reducing pain and alcohol use among individuals who experience chronic pain and heavy drinking. In addition, the study will provide a preliminary effect size estimates of the intervention on outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Compare an intervention to an assessment only control condition
| Arm | Type | Receives |
|---|---|---|
| Mobile App Intervention | Experimental | Behavioral: mhealth-pcMobile health intervention delivered through an app |
| Control | No intervention | –Assessment Only Control condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mhealth-pcParticipants meet with an interventionist who explains the rationale for the mobile app. They complete video and survey-based intervention content each week for 8 weeks. App-based sessions are supplemented with brief chat-based coaching weekly. | Behavioural | Mobile App Intervention |
Primary outcome
Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale
Time frame: 7-days
Three items with 0-10 scales to assess chronic pain based on the dimensions of pain severity, impact on enjoyment in life, and interference with activity. Range 0-30. Higher scores reflect worse outcomes
Time Line Follow-Back-30 Day Weekly Drinking
Time frame: past 30 days
Average number of drinks per week over the past 30 days. Higher scores reflect worse outcomes.
3 secondary outcomes
Time Line Follow-Back 30-Day Heavy Episodic Drinking
Time frame: past 30 days
Perceptions of Treatment Questionnaire
Time frame: Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)
Systems Usability Scale
Time frame: Current perception of intervention assessed 12 weeks following baseline (4 weeks following intervention completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhealth-pc in people with Alcohol Drinking and Chronic Pain, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale (time frame: 7-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.