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Stepped Care for Patients to Optimize Whole Recovery (SC-POWR)

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ClinicalTrials.gov Identifier: NCT05155163
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : August 26, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Chronic Pain Behavioral: SC-POWR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stepped Care for Patients to Optimize Whole Recovery
Actual Study Start Date : August 18, 2022
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in composite illicit opioid use and pain interference [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]
    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 :
  1. Change in alcohol use [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]
    Measured by the TLFB. The Timeline Followback for alcohol uses a calendar to record amount of alcohol consumed over a desired time period.

  2. Change in anxiety [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]
    Measured by the Generalized Anxiety Scale - 2 item (GAD2). Higher scores mean greater anxiety.

  3. Change in depression [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]
    Measured by the Patient Health Questionnaire-2 (PHQ-2). Higher scores on the PHQ-2 mean more symptoms of depression.

  4. Change in pain intensity [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]
    Measured by the Brief Pain Inventory (BPI), which is a measure of chronic pain. Higher scores mean greater levels of pain.

  5. Change in sleep [ Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48 ]
    Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.

  6. Change in stress [ Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48 ]
    Measured by the Perceived Stress Scale, 10-item self- report scale. Higher scores indicate greater levels of stress.

  7. Retention in MOUD [ Time Frame: 48 weeks ]
    Time from baseline until patient misses10 consecutive days of MOUD (based on dosing information from electronic health record)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >= 18 years old
  • Seeking treatment or currently enrolled at APT Foundation
  • Has persistent pain that interferes with daily life
  • Meet DSM-5 criteria for moderate to severe OUD
  • Have an opioid-positive urine test
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155163


Contacts
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Contact: Declan Barry, PhD 203-285-2708 declan.barry@yale.edu
Contact: Elizabeth Porter, MBA 203-737-3347 elizabeth.porter@yale.edu

Locations
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United States, Connecticut
APT Foundation Recruiting
North Haven, Connecticut, United States, 06473
Contact: Kim DiMeola, MA    203-781-4600    kdimeola@aptfoundation.org   
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Declan Barry Yale School of Medicine
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT05155163    
Other Study ID Numbers: 2000031094
1RM1DA055310-01 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders