NCT05588726

Improving Insomnia in Patients With Opioid Use Disorder

Behavioral Intervention to Improve Insomnia Symptoms in Patients With Opioid Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Hygiene	Once weekly coaching calls with advice on sleep hygiene
BEHAVIORAL	Mindfulness	Once weekly coaching calls with advice on mindfulness

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2022-10-20
• Last updated: 2023-05-25

Locations

1 site across 1 country: United States