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NCT06157840 | NOT YET RECRUITING | Opioid Use Disorder

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

Medical University of South Carolina

Information provided by (Responsible Party):

Allison Wilkerson

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.

Condition or disease

Opioid Use Disorder

Poor Quality Sleep

Intervention/treatment

mHealth application and sleep health education

Simplified mHealth application and sleep health education

Phase

NA

Detailed Description:

This pilot randomized controlled trial will assess the feasibility and acceptability of an evidence-based behavioral sleep intervention delivered via a mHealth app to individuals initiating treatment with medications for opioid use disorder. Additional outcomes include changes in sleep disturbance over the course of the 6-week intervention. Participants (N=40, 20 per group) will be randomized to download the mHealth app to their smartphones and complete the intervention within 6 weeks. The control group will receive a simplified version of the app with sleep hygiene instructions. Both groups will 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. At the end of the 6th week, they will complete an online series of questionnaires, including validated feasibility/acceptability measures and measures of insomnia severity.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2026-02-01
Estimated Study Completion Date : 2026-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Development of an mHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD

Location Details

NCT06157840

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Locations

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