Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05155163
Study type Interventional
Source Yale University
Contact Declan Barry, PhD
Phone 203-285-2708
Email declan.barry@yale.edu
Status Recruiting
Phase N/A
Start date June 28, 2023
Completion date August 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain