Clincosm LogoSign in Get a demo

OUDInsomnia: Improving Insomnia in Patients With Opioid Use Disorder

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05588726
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep Hygiene
  • Behavioral: Mindfulness
 N/A

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
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be conducted as a parallel, single-blinded pilot study for reducing insomnia among patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. All subjects will participate in some form of insomnia treatment over a fourteen-day period (either the mindfulness relaxation therapy with sleep hygiene or only sleep hygiene for controls). Consent and screening will occur on Day -7, and the sleep diary will be assigned for baseline measurement. Randomization and survey baseline measurements from eligible participants will occur on Day -1, and participants will be randomized into one of two arms: one arm consisting of only the sleep hygiene intervention and the other consisting of both the sleep hygiene and mindfulness interventions. On Day 28, two weeks post-intervention(s), surveys will be emailed to participants to track any changes in sleep quality, mean buprenorphine dose, and frequency of non-prescribed opioid use.This will be conducted as a parallel, single-blinded pilot study for reducing insomnia among patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. All subjects will participate in some form of insomnia treatment over a fourteen-day period (either the mindfulness relaxation therapy with sleep hygiene or only sleep hygiene for controls). Consent and screening will occur on Day -7, and the sleep diary will be assigned for baseline measurement. Randomization and survey baseline measurements from eligible participants will occur on Day -1, and participants will be randomized into one of two arms: one arm consisting of only the sleep hygiene intervention and the other consisting of both the sleep hygiene and mindfulness interventions. On Day 28, two weeks post-intervention(s), surveys will be emailed to participants to track any changes in sleep quality, mean buprenorphine dose, and frequency of non-prescribed opioid use.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Behavioral Intervention to Improve Insomnia Symptoms in Patients With Opioid Use Disorder
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sleep Hygiene

Behavioral: Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene
Experimental: Mindfulness

Behavioral: Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene

Behavioral: Mindfulness
Once weekly coaching calls with advice on mindfulness

Outcome Measures

Primary Outcome Measures

  1. Sleep Onset Latency [Day 28]

    Time to fall asleep as derived from the Sleep Diary

Secondary Outcome Measures

  1. Non-Prescribed Opioid Use [Days -1, 7, 14, and 28]

    Non-Prescribed Opioid Use Questionnaire

  2. Daytime Cravings [Days 1 through 14]

    Smartphone app usage during the day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Perelman School of Medicine, University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05588726
Other Study ID Numbers:
  • 844147
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Mindfulness
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Opioid-Related Disorders
Substance-Related Disorders

Study Results

No Results Posted as of Oct 20, 2022