Stepped Care for Patients to Optimize Whole Recovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stepped Care for Patients to Optimize Whole Recovery

Conditions
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Opioid Use Disorder, Chronic Pain

Intervention / Treatment
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* Behavioral: SC-POWR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>Treatment as usual for opioid use disorder | |
| Experimental: SC-POWR<br>Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction | Behavioral: SC-POWR<br>* Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, weekly for 24 weeks, weeks 36 and 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, weekly for 24 weeks, weeks 36 and 48 | 
| Change in anxiety | Measured by the Generalized Anxiety Scale - 2 item (GAD2). Higher scores mean greater anxiety. | Baseline, monthly for 24 weeks, weeks 36 and 48 | 
| Change in depression | Measured by the Patient Health Questionnaire-2 (PHQ-2). Higher scores on the PHQ-2 mean more symptoms of depression. | Baseline, monthly for 24 weeks, weeks 36 and 48 | 
| 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. | Baseline, weekly for 24 weeks, weeks 36 and 48 | 
| Change in sleep | Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep. | Baseline, weekly for 24 weeks, weeks 36 and 48 | 
| Change in stress | Measured by the Perceived Stress Scale, 10-item self- report scale. Higher scores indicate greater levels of stress. | Baseline, monthly for 24 weeks, weeks 36 and 48 | 
| Retention in MOUD | Time from baseline until patient misses10 consecutive days of MOUD (based on dosing information from electronic health record) | 48 weeks |