Clinical trial NCT04433975: Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
Official title: Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Medication Assisted Treatment
Chronic Pain
Keywords: Psychosocial Pain Management
Buprenorphine
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: US Department of Veterans Affairs
First posted: 2020-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Retention on buprenorphine treatment according to TimeLine Follow-Back
timeFrame: Up to 3-months post enrollment
Secondary outcomes:
measure: Retention on buprenorphine treatment according to TimeLine Follow-Back
timeFrame: Up to 12-months post enrollment
measure: Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
timeFrame: Up to 3-months post enrollment
measure: Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
timeFrame: Up to 3-months post enrollment
measure: Percent days abstinent from substance use on the TimeLine Follow-Back
timeFrame: Up to 3-months post enrollment
measure: Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
timeFrame: Up to 12-months post enrollment
measure: Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
timeFrame: Up to 12-months post enrollment
measure: Percent days abstinent from substance use on the TimeLine Follow-Back
timeFrame: Up to 12-months post enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Veterans Affair Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Allison Lin, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Mark Ilgen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: