Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (Persist)
Primary Purpose
Opioid-use Disorder, Medication Assisted Treatment, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Pain Management (PPMI)
Enhanced Usual Care (EUC)
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid-use Disorder focused on measuring Psychosocial Pain Management, Buprenorphine
Eligibility Criteria
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
Sites / Locations
- Veterans Affair Ann Arbor Healthcare SystemRecruiting
- Michigan MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psychosocial Pain Management (PPMI)
Enhanced Usual Care (EUC)
Arm Description
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Two individual telephone educational sessions with research study therapist.
Outcomes
Primary Outcome Measures
Retention on buprenorphine treatment according to TimeLine Follow-Back
Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1- and 3-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
Secondary Outcome Measures
Retention on buprenorphine treatment according to TimeLine Follow-Back
Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
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 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized 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 each follow-up (1- and 3-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1- and 3-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Percent days abstinent from substance use on the TimeLine Follow-Back
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1- and 3-month follow-ups. 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 the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. 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.
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
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 1-, 3-, 6-, 9-, and 12-month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized 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 each follow-up (1-, 3-, 6-, 9-, and 12-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1-, 3-, 6-, 9-, and 12-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Percent days abstinent from substance use on the TimeLine Follow-Back
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. 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 the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. 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.
Full Information
NCT ID
NCT04433975
First Posted
June 12, 2020
Last Updated
March 30, 2023
Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH), US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT04433975
Brief Title
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
Acronym
Persist
Official Title
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH), US Department of Veterans Affairs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Medication Assisted Treatment, Chronic Pain
Keywords
Psychosocial Pain Management, Buprenorphine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychosocial Pain Management (PPMI)
Arm Type
Experimental
Arm Description
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
Two individual telephone educational sessions with research study therapist.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Pain Management (PPMI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention on buprenorphine treatment according to TimeLine Follow-Back
Description
Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1- and 3-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
Time Frame
Up to 3-months post enrollment
Secondary Outcome Measure Information:
Title
Retention on buprenorphine treatment according to TimeLine Follow-Back
Description
Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
Time Frame
Up to 12-months post enrollment
Title
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
Description
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 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 3-months post enrollment
Title
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
Description
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized 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 each follow-up (1- and 3-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 3-months post enrollment
Title
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
Description
Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1- and 3-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 3-months post enrollment
Title
Percent days abstinent from substance use on the TimeLine Follow-Back
Description
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1- and 3-month follow-ups. 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 the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. 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.
Time Frame
Up to 3-months post enrollment
Title
Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
Description
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 1-, 3-, 6-, 9-, and 12-month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 12-months post enrollment
Title
Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
Description
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized 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 each follow-up (1-, 3-, 6-, 9-, and 12-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 12-months post enrollment
Title
Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
Description
Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1-, 3-, 6-, 9-, and 12-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
Time Frame
Up to 12-months post enrollment
Title
Percent days abstinent from substance use on the TimeLine Follow-Back
Description
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. 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 the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. 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.
Time Frame
Up to 12-months post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandy Lewis, MS
Phone
734-474-0702
Email
mstinchc@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Lin, M.D., M.S.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Ilgen, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affair Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Lewis, MS
Phone
734-474-0702
Email
mandy.lewis1@va.gov
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Lewis, MS
Phone
734-936-1386
Email
mstinchc@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Mark Ilgen, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
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