Trial Outcomes & Findings for Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (NCT NCT04433975)

NCT ID: NCT04433975

Last Updated: 2025-07-09

Results Overview

In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

3-months post enrollment

Results posted on

2025-07-09

Participant Flow

IRB approval from the University of Michigan (UM) was obtained in February 2020 with remote recruitment changes approved in June 2020. Several of the recruitment strategies used were in person recruitment at local buprenorphine clinics; posted flyers at community locations; targeted advertising on Facebook, Instagram, and Craigslist; posts on the UMHealthResearch.org page; advertising on websites that target patients in recovery; review of health records at UM and Ann Arbor VA Healthcare System

Participant milestones

Participant milestones
Measure
Psychosocial Pain Management (PPMI)
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Completed Baseline and Randomized
STARTED
98
102
Completed Baseline and Randomized
COMPLETED
98
102
Completed Baseline and Randomized
NOT COMPLETED
0
0
1-month Follow Up
STARTED
98
102
1-month Follow Up
Completed Interview
81
82
1-month Follow Up
COMPLETED
76
76
1-month Follow Up
NOT COMPLETED
22
26
3-month Follow Up
STARTED
97
101
3-month Follow Up
Completed Interview
78
84
3-month Follow Up
COMPLETED
74
77
3-month Follow Up
NOT COMPLETED
23
24
6-month Follow Up
STARTED
94
101
6-month Follow Up
Completed Interview
72
74
6-month Follow Up
COMPLETED
70
72
6-month Follow Up
NOT COMPLETED
24
29
9-month Follow Up
STARTED
93
100
9-month Follow Up
Completed Interview
69
70
9-month Follow Up
COMPLETED
66
63
9-month Follow Up
NOT COMPLETED
27
37
12-month Follow Up
STARTED
93
99
12-month Follow Up
Completed Interview
68
73
12-month Follow Up
COMPLETED
66
68
12-month Follow Up
NOT COMPLETED
27
31

Reasons for withdrawal

Reasons for withdrawal
Measure
Psychosocial Pain Management (PPMI)
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
1-month Follow Up
Withdrawal by Subject
1
1
1-month Follow Up
Lost to Follow-up
21
25
3-month Follow Up
Lost to Follow-up
20
24
3-month Follow Up
Death
1
0
3-month Follow Up
Withdrawal by Subject
2
0
6-month Follow Up
Lost to Follow-up
23
28
6-month Follow Up
Withdrawal by Subject
1
1
9-month Follow Up
Lost to Follow-up
27
36
9-month Follow Up
Death
0
1
12-month Follow Up
Lost to Follow-up
27
31

Baseline Characteristics

Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Psychosocial Pain Management (PPMI)
n=98 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=102 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Total
n=200 Participants
Total of all reporting groups
Age, Continuous
42.37 years
STANDARD_DEVIATION 10.79 • n=5 Participants
44.68 years
STANDARD_DEVIATION 10.78 • n=7 Participants
43.55 years
STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male
Female
57 Participants
n=5 Participants
58 Participants
n=7 Participants
115 Participants
n=5 Participants
Sex: Female, Male
Male
41 Participants
n=5 Participants
44 Participants
n=7 Participants
85 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=5 Participants
4 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
88 Participants
n=5 Participants
97 Participants
n=7 Participants
185 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 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
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
12 Participants
n=5 Participants
8 Participants
n=7 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
White
75 Participants
n=5 Participants
90 Participants
n=7 Participants
165 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Region of Enrollment
United States
98 participants
n=5 Participants
102 participants
n=7 Participants
200 participants
n=5 Participants
Military Status
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
Brief Pain Inventory (BPI) Score
4.7 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
4.8 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
4.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
Percent days abstinent
51.3 percent
STANDARD_DEVIATION 33.2 • n=5 Participants
50.9 percent
STANDARD_DEVIATION 34.0 • n=7 Participants
51.1 percent
STANDARD_DEVIATION 33.6 • n=5 Participants
Numeric Rating Scale (NRS-I) Score
7.43 units on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
7.55 units on a scale
STANDARD_DEVIATION 1.26 • n=7 Participants
7.49 units on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
Rapid Opioid Dependence Screen (RODS)
6.22 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
6.04 units on a scale
STANDARD_DEVIATION 1.52 • n=7 Participants
6.13 units on a scale
STANDARD_DEVIATION 1.44 • n=5 Participants
Severity of Opioid Use Disorder
Mild
8 Participants
n=5 Participants
13 Participants
n=7 Participants
21 Participants
n=5 Participants
Severity of Opioid Use Disorder
Moderate
11 Participants
n=5 Participants
14 Participants
n=7 Participants
25 Participants
n=5 Participants
Severity of Opioid Use Disorder
Severe
79 Participants
n=5 Participants
75 Participants
n=7 Participants
154 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 3-months post enrollment

In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=98 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=102 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
81.1 days
Standard Deviation 26.6
75.4 days
Standard Deviation 32.3

SECONDARY outcome

Timeframe: 12-months post enrollment

In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 12 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 12-month follow-up.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=98 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=102 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months
252.1 days
Standard Deviation 135.5
236.5 days
Standard Deviation 148.9

SECONDARY outcome

Timeframe: 3-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0=no pain, 10= worst pain imaginable), which will be collected at the baseline enrollment assessment and 3-month follow-up. To calculate our measure, we subtracted each participant's score at 3-month assessment and subtracted it from their baseline score. We then averaged calculated average change in scores for each intervention group.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=77 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=77 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline)
-0.7 score on a scale
Standard Deviation 1.4
-1.1 score on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: 3-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 3-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=74 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=76 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline)
-0.3 score on a scale
Standard Deviation 2.1
-0.8 score on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: 3-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at 3-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 3 months follow-up.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=85 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=86 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months
76.7 percent of days
Standard Deviation 37.5
74.2 percent of days
Standard Deviation 37.8

SECONDARY outcome

Timeframe: 12-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 12-month follow-up. For each follow-up time point, the baseline value will be subtracted to obtain a change score.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=66 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=68 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline)
-1.5 score on a scale
Standard Deviation 2.2
-1.9 score on a scale
Standard Deviation 2.6

SECONDARY outcome

Timeframe: 12-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 12-month follow-up. BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, the baseline value will be subtracted to obtain a change score.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=62 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=67 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline)
-0.6 score on a scale
Standard Deviation 2.9
-0.9 score on a scale
Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12-months post enrollment

Population: Participants were not required to answer every survey question. Number of participants analyzed reflects number of participants who provided data for this survey question.

Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the 12-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the treatment group average percent of days that participants were abstinent from substances after 12 months follow-up.

Outcome measures

Outcome measures
Measure
Psychosocial Pain Management (PPMI)
n=68 Participants
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=73 Participants
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months
74.7 percent of days
Standard Deviation 35.2
79.6 percent of days
Standard Deviation 32.0

Adverse Events

Psychosocial Pain Management (PPMI)

Serious events: 20 serious events
Other events: 10 other events
Deaths: 1 deaths

Enhanced Usual Care (EUC)

Serious events: 16 serious events
Other events: 7 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Psychosocial Pain Management (PPMI)
n=98 participants at risk
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=102 participants at risk
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Psychiatric disorders
Hospitalization - psych
4.1%
4/98 • Number of events 5 • 12 months
3.9%
4/102 • Number of events 4 • 12 months
General disorders
Hospitalization - general medical
16.3%
16/98 • Number of events 28 • 12 months
12.7%
13/102 • Number of events 18 • 12 months

Other adverse events

Other adverse events
Measure
Psychosocial Pain Management (PPMI)
n=98 participants at risk
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist. Psychosocial Pain Management (PPMI): The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
Enhanced Usual Care (EUC)
n=102 participants at risk
Two individual telephone educational sessions with research study therapist. Enhanced Usual Care (EUC): The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
General disorders
Emergency Medical Visit
3.1%
3/98 • Number of events 3 • 12 months
0.00%
0/102 • 12 months
General disorders
Car Accident
1.0%
1/98 • Number of events 1 • 12 months
0.00%
0/102 • 12 months
General disorders
Detox
1.0%
1/98 • Number of events 1 • 12 months
3.9%
4/102 • Number of events 4 • 12 months
General disorders
Residential Substance Use Treatment
2.0%
2/98 • Number of events 2 • 12 months
4.9%
5/102 • Number of events 6 • 12 months
General disorders
Injury - Fall
3.1%
3/98 • Number of events 3 • 12 months
0.00%
0/102 • 12 months

Additional Information

Dr. Mark Ilgen

University of Michigan Medical School

Phone: 734-845-3646

Results disclosure agreements

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