Clinical trial NCT05155163: Stepped Care for Patients to Optimize Whole Recovery
Official title: Stepped Care for Patients to Optimize Whole Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Chronic Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized clinical trial of 204 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 pain interference (Aim 1) and decrease illicit opioid use, 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 on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

Detailed description: Participants who meet criteria for CP and OUD (N=204) 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.

Eligibility criteria: Inclusion Criteria:

* Seeking treatment at APT Foundation
* Receiving medications for opioid use disorder (MOUD provided by APT)
* Have high impact chronic pain (\>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work)
* Meet DSM-5 criteria for moderate to severe OUD
* In the past 2 months, has 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
* Psychiatric instability (e.g., recent suicide attempt)
* Have a contraindication to exercise (e.g. complete heart block)
* Have a pending or planned relocation or pending incarceration

Primary outcomes:
measure: Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
Secondary outcomes:
measure: Change in alcohol use
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
measure: Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
measure: Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, monthly for 24 weeks, weeks 36 and 48
measure: Change in pain intensity assessed using the Brief Pain Inventory (BPI)
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
measure: Change in sleep
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
measure: Change in stress assessed using the Perceived Stress Scale (PSS)
timeFrame: Baseline, monthly for 24 weeks, weeks 36 and 48
measure: Change in composite illicit opioid use
timeFrame: Baseline, weekly for 24 weeks, weeks 36 and 48
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
city: North Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Declan Barry
role: PRINCIPAL_INVESTIGATOR
References: