Recruiting

Cognitive Behavioral Therapy

Sponsor:

Medical University of South Carolina

Code:

NCT06157840

Conditions

Opioid Use Disorder

Poor Quality Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mHealth application and sleep health education

Simplified mHealth application and sleep health education

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Poor Quality Sleep

Study ID

NCT06157840

Start date

Aug 25, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • No experience of withdrawal symptoms in past 2 weeks
  • Being stabilized on buprenorphine

1. Initiated buprenorphine in past 3 months
2. Modified buprenorphine dose in past 3 months (e.g., reducing dose with goal of transitioning to vivitrol)
  • Currently experiencing clinically significant sleep disturbance (PSQI > 5)
  • Able to read and understand English
  • Owns an Android or iOS smartphone
  • At least 18 years of age

Exclusion Criteria:

  • Current psychotic symptoms
  • Current active suicidal ideation
  • Severe visual impairment
  • Current use of benzodiazepines
  • Current severe SUD other than OUD (i.e., > 5 criteria met for any other SUD type per DSM-5)
  • Peripartum women

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mHealth application

Study participants, while being stabilized on buprenorphine, will download and engage with the developed mHealth application, completing daily electronic sleep diaries for the next 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.

experimental: Control Group

Participants in the control group will receive a simplified version of the app with sleep hygiene (SH) instructions and will be required to complete daily electronic sleep diaries for the next 6 weeks. The SH condition will utilize the same application and entail the same daily and weekly logs, but with the didactic material replaced by detailed education about SH strategies. Each week, participants will be asked to complete a brief assessment of their experiences from the previous week and their current insomnia severity.

Interventions

mHealth application and sleep health education

Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity

Simplified mHealth application and sleep health education

Study participants will download the mHealth app to their smartphones and complete the intervention within 6 weeks. They will receive a simplified version of the app with sleep hygiene instructions and will be required to complete daily electronic sleep diaries for the following 6 weeks. Each week, they will be asked to complete a short assessment of their experiences from the previous week and their current insomnia severity.

Primary outcome measure

  • Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages [ Time Frame: 6 weeks following enrollment ]
  • Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement [ Time Frame: 6 weeks following enrollment ]
  • mHealth App Usability Questionnaire [ Time Frame: 6 weeks following enrollment ]

Central Contacts and Locations

Central contacts

Allison K Willkerson, Ph.D.

843-792-4636wilkersa@musc.edu

Jacelyn Lane

lanejac@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29464

Contacts

Allison Wilkerson, PhD

8437924636wilkersa@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-12.