Improving Insomnia in Patients With Opioid Use Disorder (OUDInsomnia)

May 23, 2023 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman School of Medicine, University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness
Behavioral: Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene
Behavioral: Mindfulness
Once weekly coaching calls with advice on mindfulness
Active Comparator: Sleep Hygiene
Behavioral: Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Onset Latency
Time Frame: Day 28
Time to fall asleep as derived from the Sleep Diary
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Prescribed Opioid Use
Time Frame: Days -1, 7, 14, and 28
Non-Prescribed Opioid Use Questionnaire
Days -1, 7, 14, and 28
Daytime Cravings
Time Frame: Days 1 through 14
Smartphone app usage during the day
Days 1 through 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Nalaka Gooneratne, MD, MSc, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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