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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Once weekly coaching calls with advice on sleep hygiene
Once weekly coaching calls with advice on mindfulness
Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sleep Onset Latency
Time to fall asleep as derived from the Sleep Diary
Time frame: Day 28
Non-Prescribed Opioid Use
Non-Prescribed Opioid Use Questionnaire
Time frame: Days -1, 7, 14, and 28
Daytime Cravings
Smartphone app usage during the day
Time frame: Days 1 through 14
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