Chronic Pain, Medication Assisted Treatment, Opioid-use Disorder
Conditions
Keywords
Psychosocial Pain Management, Buprenorphine
Brief summary
The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.
Interventions
BEHAVIORALPsychosocial 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.
BEHAVIORALEnhanced 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
US Department of Veterans Affairs
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* having a diagnosis of an opioid use disorders (OUD) within the past 12 months; * started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months * at least moderate or greater self-reported pain on average over the past 3 months; * regular and consistent access to a telephone and willingness to use the phone for study sessions.
Exclusion criteria
* buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch * self-reported pregnancy at the time of study enrollment * currently living outside of the United States
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 3-months post enrollment | 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. |
| 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) | 3-months post enrollment | 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. |
| Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months | 3-months post enrollment | 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. |
| Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months | 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. |
| 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) | 12-months post enrollment | 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. |
| Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months | 12-months post enrollment | 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. |
| 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) | 12-months post enrollment | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 102 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow Up | Lost to Follow-up | 27 | 31 |
| 1-month Follow Up | Lost to Follow-up | 21 | 25 |
| 1-month Follow Up | Withdrawal by Subject | 1 | 1 |
| 3-month Follow Up | Death | 1 | 0 |
| 3-month Follow Up | Lost to Follow-up | 20 | 24 |
| 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 | Death | 0 | 1 |
| 9-month Follow Up | Lost to Follow-up | 27 | 36 |
Baseline characteristics
| Characteristic | Enhanced Usual Care (EUC) | Psychosocial Pain Management (PPMI) | Total |
|---|---|---|---|
| Age, Continuous | 44.68 years STANDARD_DEVIATION 10.78 | 42.37 years STANDARD_DEVIATION 10.79 | 43.55 years STANDARD_DEVIATION 10.82 |
| Brief Pain Inventory (BPI) Score | 4.8 units on a scale STANDARD_DEVIATION 2.4 | 4.7 units on a scale STANDARD_DEVIATION 2.2 | 4.8 units on a scale STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 88 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Military Status | 5 Participants | 2 Participants | 7 Participants |
| Numeric Rating Scale (NRS-I) Score | 7.55 units on a scale STANDARD_DEVIATION 1.26 | 7.43 units on a scale STANDARD_DEVIATION 1.28 | 7.49 units on a scale STANDARD_DEVIATION 1.28 |
| Percent days abstinent | 50.9 percent STANDARD_DEVIATION 34 | 51.3 percent STANDARD_DEVIATION 33.2 | 51.1 percent STANDARD_DEVIATION 33.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) White | 90 Participants | 75 Participants | 165 Participants |
| Rapid Opioid Dependence Screen (RODS) | 6.04 units on a scale STANDARD_DEVIATION 1.52 | 6.22 units on a scale STANDARD_DEVIATION 1.36 | 6.13 units on a scale STANDARD_DEVIATION 1.44 |
| Region of Enrollment United States | 102 participants | 98 participants | 200 participants |
| Severity of Opioid Use Disorder Mild | 13 Participants | 8 Participants | 21 Participants |
| Severity of Opioid Use Disorder Moderate | 14 Participants | 11 Participants | 25 Participants |
| Severity of Opioid Use Disorder Severe | 75 Participants | 79 Participants | 154 Participants |
| Sex: Female, Male Female | 58 Participants | 57 Participants | 115 Participants |
| Sex: Female, Male Male | 44 Participants | 41 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 98 | 1 / 102 |
| other Total, other adverse events | 10 / 98 | 7 / 102 |
| serious Total, serious adverse events | 20 / 98 | 16 / 102 |
Outcome results
Primary
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
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.
Time frame: 3-months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months | 81.1 days | Standard Deviation 26.6 |
| Enhanced Usual Care (EUC) | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months | 75.4 days | Standard Deviation 32.3 |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | 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 |
| Enhanced Usual Care (EUC) | 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) | -1.9 score on a scale | Standard Deviation 2.6 |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | 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 |
| Enhanced Usual Care (EUC) | 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) | -1.1 score on a scale | Standard Deviation 2.2 |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | 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 |
| Enhanced Usual Care (EUC) | 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) | -0.9 score on a scale | Standard Deviation 2.5 |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | 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 |
| Enhanced Usual Care (EUC) | 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) | -0.8 score on a scale | Standard Deviation 2.2 |
Secondary
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months | 74.7 percent of days | Standard Deviation 35.2 |
| Enhanced Usual Care (EUC) | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months | 79.6 percent of days | Standard Deviation 32 |
Secondary
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months | 76.7 percent of days | Standard Deviation 37.5 |
| Enhanced Usual Care (EUC) | Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months | 74.2 percent of days | Standard Deviation 37.8 |
Secondary
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months
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.
Time frame: 12-months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Pain Management (PPMI) | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months | 252.1 days | Standard Deviation 135.5 |
| Enhanced Usual Care (EUC) | Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months | 236.5 days | Standard Deviation 148.9 |