ACTIVE_NOT_RECRUITING

Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.

Official Title

Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder

Quick Facts

Study Start:2023-05-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05571917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
  2. 2. Willing to comply with all study procedures and be available for the duration of the study.
  3. 3. Aged 18 years or older.
  4. 4. Enrolled as a patient in one of the participating clinics.
  5. 5. Presence of chronic pain for \> 6 months in duration.
  1. 1. Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
  2. 2. Unable to read English.
  3. 3. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Contacts and Locations

Principal Investigator

Katie Witkiewitz, PhD
PRINCIPAL_INVESTIGATOR
University of New Mexico

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States

Collaborators and Investigators

Sponsor: University of New Mexico

  • Katie Witkiewitz, PhD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-05-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Chronic Pain