Stepped Care for Patients to Optimize Whole Recovery (SC-POWR)
Primary Purpose
Opioid Use Disorder, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SC-POWR
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria:
- >= 18 years old
- Seeking treatment at APT Foundation
- Receiving medications for opioid use disorder (MOUD provided by APT)
- Current APT MOUD episode is 12 months or less
- Has persistent pain that interferes with daily life
- Meet DSM-5 criteria for moderate to severe OUD
- In the past 2 months, Hhavehas an opioid-positive urine test or self-reports opioid use
- Understand English
- Able to provide informed consent
Exclusion Criteria:
- Have pending surgery or invasive pain management procedure
- Acutely psychotic, suicidal, or homicidal
- Have a contraindication to exercise (e.g. complete heart block)
- Have a pending or planned relocation or pending incarceration
Sites / Locations
- APT FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual
SC-POWR
Arm Description
Treatment as usual for opioid use disorder
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Outcomes
Primary Outcome Measures
Change in composite illicit opioid use and pain interference
Opioid use is measured by the Timeline Followback (TLFB) and confirmed by urine drug testing. The TLFB uses a calendar to measure opioid or other drug use over a desired time period; it is a self-reported measure of drug use. To confirm the self report, a urine test will be performed to detect the presence of opioids. Pain interference is measured using the Brief Pain Inventory (BPI), an 11-item scale which is a self report of pain from 0 (no pain) to 10 (worst pain). The composite outcome will take into account reductions in both illicit opioid use and pain interference.
Secondary Outcome Measures
Change in alcohol use
Measured by the TLFB. The Timeline Followback for alcohol uses a calendar to record amount of alcohol consumed over a desired time period.
Change in anxiety
Measured by the Generalized Anxiety Scale - 2 item (GAD2). Higher scores mean greater anxiety.
Change in depression
Measured by the Patient Health Questionnaire-2 (PHQ-2). Higher scores on the PHQ-2 mean more symptoms of depression.
Change in pain intensity
Measured by the Brief Pain Inventory (BPI), which is a measure of chronic pain. Higher scores mean greater levels of pain.
Change in sleep
Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.
Change in stress
Measured by the Perceived Stress Scale, 10-item self- report scale. Higher scores indicate greater levels of stress.
Retention in MOUD
Time from baseline until patient misses10 consecutive days of MOUD (based on dosing information from electronic health record)
Full Information
NCT ID
NCT05155163
First Posted
December 7, 2021
Last Updated
January 10, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05155163
Brief Title
Stepped Care for Patients to Optimize Whole Recovery
Acronym
SC-POWR
Official Title
Stepped Care for Patients to Optimize Whole Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized clinical trial of 316 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce illicit opioid use and pain interference (Aim 1) and decrease alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise [Wii Fit, Tai Chi] and stress reduction [relaxation training, auricular acupuncture] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response illicit opioid use, alcohol use, pain interference, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).
Detailed Description
Participants who meet criteria for CP and OUD (N=316) will be initiated onto MOUD and randomized to 24 weeks of either treatment as usual (TAU) or 24 weeks of SC-POWR. SC-POWR patients will be "stepped up" according to a priori criteria. Patients randomized to SC-POWR will receive a behavioral intervention consisting of 12 Cognitive Behavioral Therapy (CBT) sessions over a 24 week period involving improvements in substance use and pain since baseline. Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual for opioid use disorder
Arm Title
SC-POWR
Arm Type
Experimental
Arm Description
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Intervention Type
Behavioral
Intervention Name(s)
SC-POWR
Intervention Description
Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.
Primary Outcome Measure Information:
Title
Change in composite illicit opioid use and pain interference
Description
Opioid use is measured by the Timeline Followback (TLFB) and confirmed by urine drug testing. The TLFB uses a calendar to measure opioid or other drug use over a desired time period; it is a self-reported measure of drug use. To confirm the self report, a urine test will be performed to detect the presence of opioids. Pain interference is measured using the Brief Pain Inventory (BPI), an 11-item scale which is a self report of pain from 0 (no pain) to 10 (worst pain). The composite outcome will take into account reductions in both illicit opioid use and pain interference.
Time Frame
Baseline, weekly for 24 weeks, weeks 36 and 48
Secondary Outcome Measure Information:
Title
Change in alcohol use
Description
Measured by the TLFB. The Timeline Followback for alcohol uses a calendar to record amount of alcohol consumed over a desired time period.
Time Frame
Baseline, weekly for 24 weeks, weeks 36 and 48
Title
Change in anxiety
Description
Measured by the Generalized Anxiety Scale - 2 item (GAD2). Higher scores mean greater anxiety.
Time Frame
Baseline, monthly for 24 weeks, weeks 36 and 48
Title
Change in depression
Description
Measured by the Patient Health Questionnaire-2 (PHQ-2). Higher scores on the PHQ-2 mean more symptoms of depression.
Time Frame
Baseline, monthly for 24 weeks, weeks 36 and 48
Title
Change in pain intensity
Description
Measured by the Brief Pain Inventory (BPI), which is a measure of chronic pain. Higher scores mean greater levels of pain.
Time Frame
Baseline, weekly for 24 weeks, weeks 36 and 48
Title
Change in sleep
Description
Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.
Time Frame
Baseline, weekly for 24 weeks, weeks 36 and 48
Title
Change in stress
Description
Measured by the Perceived Stress Scale, 10-item self- report scale. Higher scores indicate greater levels of stress.
Time Frame
Baseline, monthly for 24 weeks, weeks 36 and 48
Title
Retention in MOUD
Description
Time from baseline until patient misses10 consecutive days of MOUD (based on dosing information from electronic health record)
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>= 18 years old
Seeking treatment at APT Foundation
Receiving medications for opioid use disorder (MOUD provided by APT)
Current APT MOUD episode is 12 months or less
Has persistent pain that interferes with daily life
Meet DSM-5 criteria for moderate to severe OUD
In the past 2 months, Hhavehas an opioid-positive urine test or self-reports opioid use
Understand English
Able to provide informed consent
Exclusion Criteria:
Have pending surgery or invasive pain management procedure
Acutely psychotic, suicidal, or homicidal
Have a contraindication to exercise (e.g. complete heart block)
Have a pending or planned relocation or pending incarceration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Declan Barry, PhD
Phone
203-285-2708
Email
declan.barry@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Porter, MBA
Phone
203-737-3347
Email
elizabeth.porter@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Declan Barry
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim DiMeola, MA
Phone
203-781-4600
Email
kdimeola@aptfoundation.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stepped Care for Patients to Optimize Whole Recovery
We'll reach out to this number within 24 hrs