Improving Insomnia in Patients With Opioid Use Disorder

NCT05588726 | Withdrawn

• 1 other identifier: 844147
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Insomnia

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

• Sleep Onset Latency

  Time to fall asleep as derived from the Sleep Diary

  Day 28

Secondary Outcomes (2)

• Non-Prescribed Opioid Use

  Days -1, 7, 14, and 28

• Daytime Cravings

  Days 1 through 14

Study Arms (2)

Sleep Hygiene

ACTIVE COMPARATOR

Behavioral: Sleep Hygiene

Mindfulness

EXPERIMENTAL

Behavioral: Sleep Hygiene; Behavioral: Mindfulness

Interventions

Sleep Hygiene BEHAVIORAL

Once weekly coaching calls with advice on sleep hygiene

Mindfulness; Sleep Hygiene

Mindfulness BEHAVIORAL

Once weekly coaching calls with advice on mindfulness

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman School of Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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.

  PMID: 25988095 BACKGROUND

• 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.

  PMID: 29933826 BACKGROUND

• 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.

  PMID: 17557450 BACKGROUND

• 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.

  PMID: 28735039 BACKGROUND

• 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.

  PMID: 32198209 BACKGROUND

• 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.

  PMID: 31404850 BACKGROUND

• 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.

  PMID: 31131668 BACKGROUND

• 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.

  PMID: 16466124 BACKGROUND

• 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.

  PMID: 27612339 BACKGROUND

• 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.

  PMID: 16983057 BACKGROUND

• 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.

  PMID: 31616793 BACKGROUND

• 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.

  PMID: 27544697 BACKGROUND

• 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.

  PMID: 28923194 BACKGROUND

• 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.

  PMID: 16534432 BACKGROUND

Related Links

• SAMHSA Results from 2018 National Survey on Drug Use and Health

MeSH Terms

Conditions

Opioid-Related Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nalaka Gooneratne, MD, MSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)