Improving Insomnia in Patients With Opioid Use Disorder
NCT ID: NCT05588726
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2022-01-01
2023-05-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
NCT06345872
Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
NCT04278586
Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain
NCT06947122
Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder
NCT05042388
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
NCT06642181
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sleep Hygiene
Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene
Mindfulness
Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene
Mindfulness
Once weekly coaching calls with advice on mindfulness
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep Hygiene
Once weekly coaching calls with advice on sleep hygiene
Mindfulness
Once weekly coaching calls with advice on mindfulness
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nalaka Gooneratne, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
SAMHSA Results from 2018 National Survey on Drug Use and Health
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
844147
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.