Improving Insomnia in Patients With Opioid Use Disorder

Not Applicable

Withdrawn

• Conditions: Insomnia; Opioid Use Disorder
• Interventions: Behavioral: Sleep Hygiene; Behavioral: Mindfulness

• Registration Number: NCT05588726
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Status Verified: 2023-05
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age greater than 18
2. Diagnosed with Opioid Use Disorder
3. Stable on Buprenorphine Maintenance Therapy for at least 4 weeks
4. At least 3 nights of greater than 30 minutes of sleep onset latency
5. Speak English above 6th grade level
6. Access to smart device

Exclusion Criteria

1. Inability to communicate verbally
2. Involved in another insomnia study
3. Medical or other factors that in the opinion of the study research team would interfere with their ability to participate in the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Sleep Hygiene	-
Mindfulness	Mindfulness	-
Sleep Hygiene	Sleep Hygiene	-

Primary Outcome Measures

Name	Time	Method
Sleep Onset Latency	Day 28	Time to fall asleep as derived from the Sleep Diary

Secondary Outcome Measures

Name	Time	Method
Daytime Cravings	Days 1 through 14	Smartphone app usage during the day
Non-Prescribed Opioid Use	Days -1, 7, 14, and 28	Non-Prescribed Opioid Use Questionnaire

Trial Locations

Locations (1)

Perelman School of Medicine, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States