Trial Outcomes & Findings for Alcohol Use and Chronic Pain Among Primary Care Patients (NCT NCT04958200)

NCT ID: NCT04958200

Last Updated: 2024-12-11

Results Overview

Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Past 30 days as assessed at the 16-week timepoint
• Results posted on: 2024-12-11

Participant Flow

There were 49 participants who signed to consent form. One person decided NOT to participate post-consent and therefore did not complete any baseline information or get randomized to condition. Therefore only 48 completed baseline and were randomized to condition

Participant milestones

Measure	Mhealth-pc for Alcohol and Chronic Pain Smartphone-based intervention 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.	Treatment As Usual In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Overall Study STARTED	24	24
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Mhealth-pc for Alcohol and Chronic Pain Smartphone-based intervention 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.	Treatment As Usual In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Overall Study Withdrawal by Subject	0	2
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Alcohol Use and Chronic Pain Among Primary Care Patients

Baseline characteristics by cohort

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 Participants Smartphone-based intervention 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.	Treatment As Usual n=24 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information	Total n=48 Participants Total of all reporting groups
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	53.17 years STANDARD_DEVIATION 13.15 • n=5 Participants	52.42 years STANDARD_DEVIATION 17.35 • n=7 Participants	52.79 years STANDARD_DEVIATION 15.23 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Number of heavy drinking episode days in the past 30 days	11.25 heavy drinking days STANDARD_DEVIATION 11.78 • n=5 Participants	8.79 heavy drinking days STANDARD_DEVIATION 8.93 • n=7 Participants	10.02 heavy drinking days STANDARD_DEVIATION 10.41 • n=5 Participants
Average number of drinks per week over the past 30 days	22.33 drinks/week STANDARD_DEVIATION 22.27 • n=5 Participants	18.36 drinks/week STANDARD_DEVIATION 15.89 • n=7 Participants	20.35 drinks/week STANDARD_DEVIATION 19.24 • n=5 Participants
Pain, Enjoyment, General Activity (PEG)	6.36 units on a scale STANDARD_DEVIATION 1.69 • n=5 Participants	5.76 units on a scale STANDARD_DEVIATION 1.83 • n=7 Participants	6.06 units on a scale STANDARD_DEVIATION 1.77 • n=5 Participants
Pain Intensity: Brief Pain Inventory	5.4 units on a scale STANDARD_DEVIATION 1.71 • n=5 Participants	4.66 units on a scale STANDARD_DEVIATION 1.46 • n=7 Participants	5.03 units on a scale STANDARD_DEVIATION 1.61 • n=5 Participants
Pain Interference: Brief Pain Inventory	6.21 units on a scale STANDARD_DEVIATION 1.88 • n=5 Participants	5.24 units on a scale STANDARD_DEVIATION 2.15 • n=7 Participants	5.72 units on a scale STANDARD_DEVIATION 2.06 • n=5 Participants

PRIMARY outcome

Timeframe: Past 30 days as assessed at the 16-week timepoint

Population: multiple imputation was used in analyses for primary outcomes only

Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)

Outcome measures

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 Participants Smartphone-based intervention 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.	Treatment As Usual n=24 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days	7.9 heavy drinking days Standard Deviation 11.32	4.3 heavy drinking days Standard Deviation 5.57

PRIMARY outcome

Timeframe: Past 30 days as assessed at the 16-week timepoint

Average number of standard alcohol-containing drinks per week over the past 30 days

Outcome measures

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 Participants Smartphone-based intervention 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.	Treatment As Usual n=24 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days	16.89 drinks per week Standard Deviation 20.60	10.56 drinks per week Standard Deviation 9.02

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 Participants Smartphone-based intervention 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.	Treatment As Usual n=24 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
The Pain, Enjoyment of Life, General Activity (PEG) Scale	4.60 score on a scale Standard Deviation 2.56	4.82 score on a scale Standard Deviation 1.79

SECONDARY outcome

Timeframe: past 7 days as assessed at the 16-week timepoint

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.

Outcome measures

Measure	Mhealth-pc for Alcohol and Chronic Pain n=21 Participants Smartphone-based intervention 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.	Treatment As Usual n=20 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Pain Intensity - Brief Pain Inventory (BPI) Items	3.98 score on a scale Standard Deviation 1.93	4.16 score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: past 7 days as assessed at the 16-week timepoint

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

Outcome measures

Measure	Mhealth-pc for Alcohol and Chronic Pain n=21 Participants Smartphone-based intervention 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.	Treatment As Usual n=20 Participants In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Pain Interference	4.37 score on a scale Standard Deviation 2.63	4.68 score on a scale Standard Deviation 2.36

Adverse Events

Mhealth-pc for Alcohol and Chronic Pain

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment As Usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 participants at risk Smartphone-based intervention 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.	Treatment As Usual n=24 participants at risk In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Injury, poisoning and procedural complications Hospitalization	0.00% 0/24 • Adverse events were collected throughout the period in which the participant was in the study which was 16-weeks.	4.2% 1/24 • Number of events 1 • Adverse events were collected throughout the period in which the participant was in the study which was 16-weeks.

Other adverse events

Measure	Mhealth-pc for Alcohol and Chronic Pain n=24 participants at risk Smartphone-based intervention 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.	Treatment As Usual n=24 participants at risk In person session that provides enhanced treatment as usual Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information
Metabolism and nutrition disorders hospital visit for uncontrolled diabetes	4.2% 1/24 • Number of events 1 • Adverse events were collected throughout the period in which the participant was in the study which was 16-weeks.	0.00% 0/24 • Adverse events were collected throughout the period in which the participant was in the study which was 16-weeks.

Additional Information

Tibor Palfai, PhD

Boston University

Phone: 6173539345

Email: palfai@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place