RECRUITING

Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD

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 to develop and test a medical health application based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in opioid use disorder. An initial program will be built utilizing input from persons beginning medications for opioid use disorders.

Official Title

Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder

Quick Facts

Study Start:2025-08-15
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06157840

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. * No experience of withdrawal symptoms in past 2 weeks
  2. * Being stabilized on buprenorphine
  3. 1. Initiated buprenorphine in past 3 months
  4. 2. Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
  5. * Currently experiencing clinically significant sleep disturbance (PSQI \> 5)
  6. * Able to read and understand English
  7. * Owns an Android or iOS smartphone
  8. * At least 18 years of age
  1. * Current psychotic symptoms
  2. * Current active suicidal ideation
  3. * Severe visual impairment
  4. * Current use of benzodiazepines
  5. * Current severe SUD other than OUD (i.e., \> 5 criteria met for any other SUD type per DSM-5)
  6. * Peripartum women

Contacts and Locations

Study Contact

Allison K Willkerson, Ph.D.
CONTACT
843-792-4636
wilkersa@musc.edu
Jacelyn Lane
CONTACT
lanejac@musc.edu

Principal Investigator

Allison K Wilkerson, Ph.D.
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29464
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Allison K Wilkerson, Ph.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2025-08-15
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Poor Quality Sleep