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Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes (Persist)

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ClinicalTrials.gov Identifier: NCT04433975
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
US Department of Veterans Affairs
Information provided by (Responsible Party):
Mark A. Ilgen, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Medication Assisted Treatment Chronic Pain Behavioral: Psychosocial Pain Management (PPMI) Behavioral: Enhanced Usual Care (EUC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychosocial Pain Management (PPMI)
Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Behavioral: 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.

Active Comparator: Enhanced Usual Care (EUC)
Two individual telephone educational sessions with research study therapist.
Behavioral: 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.




Primary Outcome Measures :
  1. Retention on buprenorphine treatment according to TimeLine Follow-Back [ Time Frame: Up to 3-months post enrollment ]
    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 :
  1. Retention on buprenorphine treatment according to TimeLine Follow-Back [ Time Frame: Up to 12-months post enrollment ]
    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.

  2. Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I). [ Time Frame: Up to 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 the 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.

  3. Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI) [ Time Frame: Up to 3-months post enrollment ]
    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.

  4. Change from baseline in self-reported level of pain related functioning on the Pain Interference measure [ Time Frame: Up to 3-months post enrollment ]
    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.

  5. Percent days abstinent from substance use on the TimeLine Follow-Back [ Time Frame: Up to 3-months post enrollment ]
    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.

  6. Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I). [ Time Frame: Up to 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 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.

  7. Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI) [ Time Frame: Up to 12-months post enrollment ]
    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.

  8. Change from baseline in self-reported level of pain related functioning on the Pain Interference measure [ Time Frame: Up to 12-months post enrollment ]
    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.

  9. Percent days abstinent from substance use on the TimeLine Follow-Back [ Time Frame: Up to 12-months post enrollment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433975


Contacts
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Contact: Brooke Houser, LLMSW 734-936-1386 bnhouser@med.umich.edu

Locations
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United States, Michigan
Veterans Affair Ann Arbor Healthcare System Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Mandy Lewis, MS    734-845-5448    mandy.lewis1@va.gov   
Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Brooke Houser, LLMSW    734-936-1386    bnhouser@med.umich.edu   
Principal Investigator: Mark Ilgen, Ph.D.         
Sponsors and Collaborators
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
US Department of Veterans Affairs
Investigators
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Principal Investigator: Allison Lin, M.D., M.S. University of Michigan
Principal Investigator: Mark Ilgen, Ph.D. University of Michigan
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Responsible Party: Mark A. Ilgen, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT04433975    
Other Study ID Numbers: HUM00166747
R33AT010106 ( U.S. NIH Grant/Contract )
R01AT010797 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark A. Ilgen, University of Michigan:
Psychosocial Pain Management
Buprenorphine
Additional relevant MeSH terms:
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Chronic Pain
Substance-Related Disorders
Pain
Neurologic Manifestations
Chemically-Induced Disorders
Mental Disorders