Clinical trial NCT06157840: Development of an MHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for MOUD
Official title: Development of an MHealth Behavioral Sleep Medicine Intervention for Use During Medication Assisted Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Poor Quality Sleep
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Enrollment feasibility/acceptability benchmark of at least 30 persons completing entire study period - Enrollment and retention percentages
timeFrame: 6 weeks following enrollment
measure: Protocol adherence feasibility/acceptability benchmarks of participants completing modules and sleep diaries each week - Engagement
timeFrame: 6 weeks following enrollment
measure: mHealth App Usability Questionnaire
timeFrame: 6 weeks following enrollment
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: At enrollment and 6 weeks following enrollment
measure: Structured Clinical Interview for Sleep Disorders - Revised Edition
timeFrame: At enrollment and 6 weeks following enrollment
measure: Insomnia Severity Index
timeFrame: At enrollment and 6 weeks following enrollment
measure: Daily Sleep Diary - Sleep Onset Latency
timeFrame: Through study completion of 6 weeks
measure: Daily Sleep Diary - Wake-time After Sleep
timeFrame: Through study completion of 6 weeks
measure: Daily Sleep Diary - Total Sleep Time
timeFrame: Through study completion of 6 weeks
measure: Daily Sleep Diary - Sleep Efficiency
timeFrame: Through study completion of 6 weeks
Other outcomes:
measure: MOUD and drug use
timeFrame: Through study completion of 6 weeks
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Allison K Wilkerson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: