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Opioid Use DisorderSC-POWRNCT05155163

Stepped Care for Patients to Optimize Whole Recovery

A study testing SC-POWR in people with Opioid Use Disorder and Chronic Pain, run by Yale University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use Disorder, Chronic Pain
What is being tested?
SC-POWR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
2 sitesUnited States
Study dates
28 Jun 2023to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • APT Foundation

    New Haven, Connecticut, 06520

  • APT Foundation

    North Haven, Connecticut, 06473

Other trials in United States

About this study

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).

Read the 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.

This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).

Being tested
SC-POWR
Medical subject headings
Opioid-Related Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC-POWRBehavioural

    Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.

Study groups in NCT05155163
Study groupRoleWhat they receive
Treatment as UsualNo interventionTreatment as usual for opioid use disorder
SC-POWRExperimentalTreatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Receives: Behavioral: SC-POWR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale

    Pain interference is measured using the PEG scale, a 3-item scale with each item scored from 0-10. Total scores are achieved by averaging the 3 items. Total sore range from 0-10. Higher scores indicate more pain and interference.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

  2. Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)

    General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

  3. Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

    PHQ-9 assesses depression symptoms. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. The scoring can also be divided into categories, with scores of 0-4 indicating minimal or no depression, 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderately severe depression, and 20 or above indicating severe depression.

    Measured: Baseline, monthly for 24 weeks, weeks 36 and 48

  4. Change in pain intensity assessed using the Brief Pain Inventory (BPI)

    The BPI has a total score range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Total pain severity score can be found by averaging all items.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

  5. Change in sleep

    Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

  6. Change in stress assessed using the Perceived Stress Scale (PSS)

    The PSS is a 10-item self- report scale. PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Total score range from 0-40 with higher scores indicate greater levels of stress.

    Measured: Baseline, monthly for 24 weeks, weeks 36 and 48

  7. Change in composite illicit opioid use

    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.

    Measured: Baseline, weekly for 24 weeks, weeks 36 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start28 Jun 2023
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155163
Sponsor's protocol ID
2000031094
Other IDs
1RM1DA055310-01
Acronym
SC-POWR
Status last verified
Apr 2026
First submitted
7 Dec 2021
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SC-POWR in people with Opioid Use Disorder and Chronic Pain, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale (time frame: Baseline, weekly for 24 weeks, weeks 36 and 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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