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NCT05588726 Clinical Trial

Improving Insomnia in Patients With Opioid Use Disorder

Insomnia Clinical Trial

— OUDInsomnia  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05588726
Other study ID # 844147
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date May 23, 2023

Study information
Verified date May 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 23, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Perelman School of Medicine, University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (14)

Ardame A, Bassaknejad S, Zargard Y, Rokni P, Sayyah M. Examine the Relationship between Mindfulness and Drug Craving in Addicts Undergoing Methadone Maintenance Treatment. Iran J Public Health. 2014 Mar;43(3):349-54. — View Citation

Chakravorty S, Vandrey RG, He S, Stein MD. Sleep Management Among Patients with Substance Use Disorders. Med Clin North Am. 2018 Jul;102(4):733-743. doi: 10.1016/j.mcna.2018.02.012. — View Citation

Dimsdale JE, Norman D, DeJardin D, Wallace MS. The effect of opioids on sleep architecture. J Clin Sleep Med. 2007 Feb 15;3(1):33-6. — View Citation

Dunn KE, Finan PH, Andrew Tompkins D, Strain EC. Frequency and correlates of sleep disturbance in methadone and buprenorphine-maintained patients. Addict Behav. 2018 Jan;76:8-14. doi: 10.1016/j.addbeh.2017.07.016. Epub 2017 Jul 14. — View Citation

Eacret D, Veasey SC, Blendy JA. Bidirectional Relationship between Opioids and Disrupted Sleep: Putative Mechanisms. Mol Pharmacol. 2020 Oct;98(4):445-453. doi: 10.1124/mol.119.119107. Epub 2020 Mar 20. — View Citation

Garland EL, Hanley AW, Kline A, Cooperman NA. Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Drug Alcohol Depend. 2019 Oct 1;203:61-65. doi: 10.1016/j.drugalcdep.2019.07.007. Epub 2019 Aug 5. — View Citation

Hallinan R, Elsayed M, Espinoza D, Veillard AS, Morley KC, Lintzeris N, Haber P. Insomnia and excessive daytime sleepiness in women and men receiving methadone and buprenorphine maintenance treatment. Subst Use Misuse. 2019;54(10):1589-1598. doi: 10.1080/10826084.2018.1552298. Epub 2019 May 26. — View Citation

Kasasbeh E, Chi DS, Krishnaswamy G. Inflammatory aspects of sleep apnea and their cardiovascular consequences. South Med J. 2006 Jan;99(1):58-67; quiz 68-9, 81. doi: 10.1097/01.smj.0000197705.99639.50. Erratum In: South Med J. 2006 Feb;99(2):163. — View Citation

Khusid MA, Vythilingam M. The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. Mil Med. 2016 Sep;181(9):969-75. doi: 10.7205/MILMED-D-14-00678. — View Citation

Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74. doi: 10.1001/archinte.166.16.1768. — View Citation

Kreek MJ, Reed B, Butelman ER. Current status of opioid addiction treatment and related preclinical research. Sci Adv. 2019 Oct 2;5(10):eaax9140. doi: 10.1126/sciadv.aax9140. eCollection 2019 Oct. — View Citation

Lydon-Staley DM, Cleveland HH, Huhn AS, Cleveland MJ, Harris J, Stankoski D, Deneke E, Meyer RE, Bunce SC. Daily sleep quality affects drug craving, partially through indirect associations with positive affect, in patients in treatment for nonmedical use of prescription drugs. Addict Behav. 2017 Feb;65:275-282. doi: 10.1016/j.addbeh.2016.08.026. Epub 2016 Aug 15. — View Citation

Serdarevic M, Osborne V, Striley CW, Cottler LB. The association between insomnia and prescription opioid use: results from a community sample in Northeast Florida. Sleep Health. 2017 Oct;3(5):368-372. doi: 10.1016/j.sleh.2017.07.007. Epub 2017 Aug 10. — View Citation

Zimmerman M, McGlinchey JB, Young D, Chelminski I. Diagnosing major depressive disorder I: A psychometric evaluation of the DSM-IV symptom criteria. J Nerv Ment Dis. 2006 Mar;194(3):158-63. doi: 10.1097/01.nmd.0000202239.20315.16. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Onset Latency Time to fall asleep as derived from the Sleep Diary Day 28
Secondary Non-Prescribed Opioid Use Non-Prescribed Opioid Use Questionnaire Days -1, 7, 14, and 28
Secondary Daytime Cravings Smartphone app usage during the day Days 1 through 14
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