Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05039554

Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

Led by Albert Einstein College of Medicine · Updated on 2026-04-15

123

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

Sponsors

A

Albert Einstein College of Medicine

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.

CONDITIONS

Official Title

Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Proficient in English or Spanish
  • Receiving buprenorphine treatment for opioid use disorder for at least 14 days with a stable dose
  • Chronic pain with moderate or greater severity (score ≥ 4 on PEG scale)
  • Comorbid psychiatric conditions and use of psychotropic medications allowed
Not Eligible

You will not qualify if you...

  • Acute psychiatric conditions preventing study participation (e.g., acute mania, active suicidality/homicidality, psychosis)
  • Changes in psychotropic medications within 3 months prior to enrollment
  • Chronic pain related to cancer
  • Previous Acceptance and Commitment Therapy or similar therapy
  • Started psychotherapy within the past 3 months
  • Neurocognitive conditions preventing access to telehealth
  • Current use of a smartphone health platform similar to the Valera app
  • Unable or unwilling to provide signed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

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Research Team

H

Hector Perez, MD

CONTACT

J

Joanna Starrels, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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