Trial Outcomes & Findings for Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings (NCT NCT03698669)

Last Updated: 2026-01-08

Results Overview

The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents "does not interfere" and 10 indicates "interferes completely."

Recruitment status

COMPLETED

Study phase

Target enrollment

163 participants

Primary outcome timeframe

3 Months

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Allocation STARTED	82	81
Allocation COMPLETED	82	81
Allocation NOT COMPLETED	0	0
Completed 3 Month Assessment STARTED	82	81
Completed 3 Month Assessment COMPLETED	60	65
Completed 3 Month Assessment NOT COMPLETED	22	16
Completed 6 Month Assessment STARTED	82	81
Completed 6 Month Assessment COMPLETED	66	64
Completed 6 Month Assessment NOT COMPLETED	16	17
Completed 9 Month Assessment STARTED	82	81
Completed 9 Month Assessment COMPLETED	63	60
Completed 9 Month Assessment NOT COMPLETED	19	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=82 Participants TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=81 Participants Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.	Total n=163 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 10.8 • n=18 Participants	43.7 years STANDARD_DEVIATION 10.4 • n=17 Participants	44.6 years STANDARD_DEVIATION 10.6 • n=35 Participants
Sex: Female, Male Female	42 Participants n=18 Participants	35 Participants n=17 Participants	77 Participants n=35 Participants
Sex: Female, Male Male	40 Participants n=18 Participants	46 Participants n=17 Participants	86 Participants n=35 Participants
Race/Ethnicity, Customized White	67 Participants n=18 Participants	74 Participants n=17 Participants	141 Participants n=35 Participants
Race/Ethnicity, Customized African American	7 Participants n=18 Participants	3 Participants n=17 Participants	10 Participants n=35 Participants
Race/Ethnicity, Customized Other	8 Participants n=18 Participants	4 Participants n=17 Participants	12 Participants n=35 Participants
Region of Enrollment United States	82 participants n=18 Participants	81 participants n=17 Participants	163 participants n=35 Participants
Pain Interference Based on the Brief Pain Inventory	6.04 units on a scale STANDARD_DEVIATION 1.57 • n=18 Participants	6.02 units on a scale STANDARD_DEVIATION 1.67 • n=17 Participants	6.03 units on a scale STANDARD_DEVIATION 1.61 • n=35 Participants
Pain Severity Based on the Brief Pain Inventory	5.68 units on a scale STANDARD_DEVIATION 1.66 • n=18 Participants	5.68 units on a scale STANDARD_DEVIATION 1.66 • n=17 Participants	5.68 units on a scale STANDARD_DEVIATION 1.66 • n=35 Participants
Patient Health Questionnaire- 9 Score	12.33 units on a scale STANDARD_DEVIATION 5.07 • n=18 Participants	12.04 units on a scale STANDARD_DEVIATION 4.96 • n=17 Participants	12.18 units on a scale STANDARD_DEVIATION 5.00 • n=35 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: These numbers represent those with non-missing data on the BPI-Interference subscale at 3 months.

Outcome measures

Outcome measures
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=59 Participants TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=64 Participants Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Pain Interference Based on the Brief Pain Inventory	5.01 units on a scale Interval 4.54 to 5.47	4.67 units on a scale Interval 4.19 to 5.47

PRIMARY outcome

Timeframe: 3 Months

Population: These numbers represent those with non-missing data on the BPI at 3 months.

Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Participants will indicate "average" pain in the last week. Scores range between 0 and 10.

Outcome measures

Outcome measures
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=59 Participants TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=64 Participants Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Pain Severity Based on the Brief Pain Inventory	5.17 units on a scale Interval 4.75 to 5.58	5.02 units on a scale Interval 4.65 to 5.39

PRIMARY outcome

Timeframe: 3 Months

The Patient Health Questionnaire (PHQ-9) will be used to measure depression severity and suicidality. It is the major depressive disorder module of the full PHQ. Scores range from 0-27, with scores less than or equal to 4 suggesting minimal depression, scores from 5 to 9 indicating mild depression, 10 to 14 indicating moderately depression, 15 to 19 reflecting moderately severe depression, and scores greater than 20 indicating severe depression.

Outcome measures

Outcome measures
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=60 Participants TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=65 Participants Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Depression Based on the Patient Health Questionnaire-9	10.91 units on a scale Interval 9.87 to 11.95	9.21 units on a scale Interval 8.13 to 10.3

SECONDARY outcome

Timeframe: Month 12

Population: At month 12, data were available for 64 of the 82 participants in the TOPPS arm and 67 of the 81 participants in the HE arm for this outcome measure.

Using clinical records at the recruitment sites or participant self-report, we will assess whether participants were engaged in buprenorphine treatment at 12 months post study baseline

Outcome measures

Outcome measures
Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=64 Participants TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=67 Participants Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Number of Participants Retained in Buprenorphine Treatment	63 Participants	61 Participants

Adverse Events

Treating Opioid Patients' Pain and Sadness (TOPPS)

Serious events: 8 serious events

Other events: 40 other events

Deaths: 1 deaths

Health Education (HE)

Serious events: 15 serious events

Other events: 54 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Michael Stein, MD

Boston University

Phone: 617 358 1956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treating Opioid Patients' Pain and Sadness (TOPPS) n=82 participants at risk TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.	Health Education (HE) n=81 participants at risk Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Psychiatric disorders Hospitalization- psychiatric	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	3.7% 3/81 • Number of events 4 • Adverse event data were collected over the course of the 12-month study period.
General disorders Hospitalization due to overdose	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	2.5% 2/81 • Number of events 2 • Adverse event data were collected over the course of the 12-month study period.
Injury, poisoning and procedural complications Hospitalization due to hernia	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Hepatobiliary disorders Hospitalization- gallbladder removal	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to sepsis	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	2.5% 2/81 • Number of events 2 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to lung infection	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Cardiac disorders Hospitalization due to myocardial infarction	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	2.5% 2/81 • Number of events 2 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to pneumonia	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Musculoskeletal and connective tissue disorders Hospitalization due to severe back pain	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Renal and urinary disorders Hospitalization due to kidney stone	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Respiratory, thoracic and mediastinal disorders Hospitalization- difficulty breathing	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Injury, poisoning and procedural complications Hospitalization due to fall	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to endocarditis	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
General disorders Hospitalization for flu symptoms	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to infection in foot	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Respiratory, thoracic and mediastinal disorders Hospitalization due to lung inflammation	0.00% 0/82 • Adverse event data were collected over the course of the 12-month study period.	1.2% 1/81 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
General disorders Hospitalization for substance use treatment	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Hospitalization due to staph infection	1.2% 1/82 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/81 • Adverse event data were collected over the course of the 12-month study period.