Alcohol DrinkingNCT04958200
Alcohol Use and Chronic Pain Among Primary Care Patients
A study testing mhealth-pc for alcohol and pain and Treatment As Usual 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 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… 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 for alcohol and pain and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Drinking, Chronic Pain
- Being tested
- mhealth-pc for alcohol and pain, Treatment As Usual
- 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-pc for alcohol and painBehavioural
Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
Treatment As UsualBehavioural
psychoeducation on pain and alcohol use and treatment resource information
| Study group | Role | What they receive |
|---|---|---|
| mhealth-pc for alcohol and chronic pain | Experimental | Smartphone-based intervention Receives: Behavioral: mhealth-pc for alcohol and pain |
| Treatment As Usual | Active comparator | In person session that provides enhanced treatment as usual Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days
Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)
Measured: Past 30 days as assessed at the 16-week timepoint
Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days
Average number of standard alcohol-containing drinks per week over the past 30 days
Measured: Past 30 days as assessed at the 16-week timepoint
The Pain, Enjoyment of Life, General Activity (PEG) Scale
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
Measured: Past 7 days as assessed at the 16-week timepoint
Secondary outcomes (2)
Pain Intensity - Brief Pain Inventory (BPI) Items
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.
Measured: past 7 days as assessed at the 16-week timepoint
Pain Interference
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
Measured: past 7 days as assessed at the 16-week timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start26 Aug 2021
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 intervention to a treatment as usual comparison condition
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Tibor Palfai, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958200
- Sponsor's protocol ID
- 4947
- Other IDs
- R34AA027598-01
- Status last verified
- Dec 2024
- First submitted
- 30 Jun 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care
- ClinicalTrials.gov ID
- NCT04958200
- Acronym / sponsor ID
- 4947
- Conditions
- Alcohol Drinking, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 11 Dec 2024
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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Compare intervention to a treatment as usual comparison condition
| Arm | Type | Receives |
|---|---|---|
| mhealth-pc for alcohol and chronic pain | Experimental | Behavioral: mhealth-pc for alcohol and painSmartphone-based intervention |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualIn person session that provides enhanced treatment as usual |
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: 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)
Key exclusion criteria (6 listed)
- 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
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-pc for alcohol and painSmartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins. | Behavioural | mhealth-pc for alcohol and chronic pain |
| Treatment As Usualpsychoeducation on pain and alcohol use and treatment resource information | Behavioural | Treatment As Usual |
Primary outcome
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)
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
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
2 secondary outcomes
Pain Intensity - Brief Pain Inventory (BPI) Items
Time frame: past 7 days as assessed at the 16-week timepoint
Pain Interference
Time frame: past 7 days as assessed at the 16-week timepoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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 for alcohol and pain and Treatment As Usual 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 6 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 11 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). The study lists 3 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 11 Dec 2024.