Behavioral Intervention to Improve Insomnia Symptoms in Patients With Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Pennsylvania
- Locations
- 2
- Primary Endpoint
- Sleep Onset Latency
Study Overview
Brief Summary
This randomized, 35-day research study (n=20) explores the effects of a simplified mindfulness intervention in opioid use disorder patients stabilized on buprenorphine maintenance therapy (BMT), aiming to alleviate insomnia, monitor BMT dose, and decrease non-prescribed opioid use. Patients tap along with their breathing at bedtime and practice sleep hygiene; controls do sleep hygiene only. Adherence will be monitored by a smartphone application.
Detailed Description
This research study is exploring the effects of a simplified mindfulness intervention in patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. This study aims to improve their sleep quality, monitor changes in buprenorphine dose, and decrease the frequency of non-prescribed opioids use. We will be enrolling a total of 20 patients who are above 18 years of age and have insomnia symptoms, opioid use disorder, and access to a smartphone. Patients will be asked to utilize a smartphone application which will allow us to monitor adherence; they will be asked to tap on the screen in time with their breathing before bedtime. Buprenorphine maintenance therapy is used to treat opioid use disorder (the buprenorphine will be prescribed by their healthcare provider as part of their standard clinical care and is not a research study intervention) by minimizing withdrawal symptoms, but symptoms of insomnia often persist. Symptoms of insomnia include difficulty falling/staying asleep, anxiety regarding sleep, or daytime sleepiness.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than 18
- •Diagnosed with Opioid Use Disorder
- •Stable on Buprenorphine Maintenance Therapy for at least 4 weeks
- •At least 3 nights of greater than 30 minutes of sleep onset latency
- •Speak English above 6th grade level
- •Access to smart device
Exclusion Criteria
- •Inability to communicate verbally
- •Involved in another insomnia study
- •Medical or other factors that in the opinion of the study research team would interfere with their ability to participate in the intervention
Outcomes
Primary Outcomes
Sleep Onset Latency
Time Frame: Day 28
Time to fall asleep as derived from the Sleep Diary
Secondary Outcomes
- Daytime Cravings(Days 1 through 14)
- Non-Prescribed Opioid Use(Days -1, 7, 14, and 28)