The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial
NCT ID: NCT03412591
Last Updated: 2024-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
28 participants
INTERVENTIONAL
2019-07-01
2023-01-07
Brief Summary
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1. To determine if suvorexant will improve sleep quality (increased total sleep time, fewer awakenings), as measured through wrist actigraphy and the Insomnia Severity Index (ISI) in SUDs.
2. To assess whether or not SUDs patients treated with suvorexant endorse scale items on a modified abuse liability assessment battery.
3. To determine if daily reports of mood, stress, craving and sleep using Ecological Momentary Assessment (EMA data) change during the course of the study as patients with SUDs are treated with suvorexant.
4. To determine if patients taking suvorexant will have a decrease in total daily salivary cortisol over the course of the study by collecting samples at five time points in a day, for two consecutive days at two different times in the study.
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Detailed Description
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Suvorexant is a novel orexin 1 and 2 receptor antagonist, FDA approved for the treatment of insomnia. Suvorexant may be differentially beneficial in patients with opioid dependence: 1) It is efficacious for treatment of insomnia in the general population, 2) Data from animal models of opioid dependence suggest that orexins may be involved in reward (opioid) seeking behavior and altered stress response while an orexin antagonist appears to decrease reward (opioid) seeking while normalizing HPA axis function. A medication that can improve sleep, decrease craving and normalize the HPA axis may theoretically be helpful in patients with SUDs. At this juncture, the literature supports the case for an open trial of Suvorexant for patients in residential care for SUDs, who complain of sleep disturbance. The patients will be at least 5 days post-withdrawal, in order to minimize the residual sleep complaints associated with that phase of treatment.
In previous, well-designed, placebo-controlled clinical trials in patients with insomnia, suvorexant has been shown to be efficacious compared with placebo. However, substance dependent patients with insomnia were not included in these studies. Although, as a new sleep medication, suvorexant has been placed in Schedule IV by the FDA, the drug has not been studied in the context of its potential abuse liability when administered at bedtime at the therapeutic dose among patients in residential treatment for substance dependence disorders. A modified abuse liability protocol will therefore be incorporated in this pilot study.
The hypothesis for this study are-
1. Relative to a baseline, patients treated with suvorexant will experience an increase in total sleep time, fewer awakenings after sleep onset, and improved subjective sleep quality.
2. Patients treated with suvorexant are not likely to endorse scale items associated with abuse liability 30 minutes after drug administration or the following morning.
3. Relative to baseline, patients being treated with suvorexant are more likely to report improved moods, and decreased ambient craving.
4. Relative to baseline, patients being treated with suvorexant are more likely to experience decreased total daily salivary cortisol over the course of 7 days of treatment with suvorexant.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label trial of suvorexant in individuals with opioid use disorder
It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder.
Suvorexant 20 mg
Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Open label trial of suvorexant in individuals with alcohol use disorder
It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder.
Suvorexant 20 mg
Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Interventions
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Suvorexant 20 mg
Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: 21-64 (inclusive) years old
3. Caron Foundation residential alcohol or opioid dependent patients that have a history of daily or near daily substance use for the month prior to admittance.
Group 1: at least five days post medically assisted withdrawal for alcohol dependence, and complain of problems falling asleep, remaining asleep after sleep onset, or poor sleep quality on current sleep medication (antidepressant/melatonin).
Group 2: at least five days post medically assisted withdrawal for opioid dependence and complain of problems falling asleep, remaining asleep after sleep onset, or poor sleep quality on current sleep medication (antidepressant/melatonin).
4. Fluent in written and spoken English.
Exclusion Criteria
2. Patients with current major depressive disorder, schizophrenia, bipolar disorder, post traumatic stress disorder, or a history of traumatic brain injury.
3. Patients with a history of narcolepsy or REM related phenomenon.
4. Patients with chronic respiratory problems including asthma, COPD, or other respiratory issues that can lead to sleep disturbances at night.
5. Patients with current suicidal ideation, or a history of previous suicide attempts.
6. Patients with severe liver impairment.
7. Women who are pregnant or breastfeeding.
8. Patients who are severely obese.
9. Decisional impairment
10. Prisoners or under legal mandate.
21 Years
64 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Scott C Bunce, PhD
Associate Professor of Psychiatry
Principal Investigators
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Venkatesh Basappa Krishnamurthy, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State University Hershey Medical Center
Locations
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Richard J Caron Foundation
Wernersville, Pennsylvania, United States
Countries
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References
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US Food and Drug Administration (2013). Suvorexant Advisory Committee Meeting briefing document.http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/peripheralandcentralnervoussystemdrugsadvisorycommittee/ucm352970.pdf. Accessed 9 Sep 2014
Smith RJ, Aston-Jones G. Orexin / hypocretin 1 receptor antagonist reduces heroin self-administration and cue-induced heroin seeking. Eur J Neurosci. 2012 Mar;35(5):798-804. doi: 10.1111/j.1460-9568.2012.08013.x. Epub 2012 Feb 22.
Giardino WJ, de Lecea L. Hypocretin (orexin) neuromodulation of stress and reward pathways. Curr Opin Neurobiol. 2014 Dec;29:103-8. doi: 10.1016/j.conb.2014.07.006. Epub 2014 Jul 20.
Koob G, Kreek MJ. Stress, dysregulation of drug reward pathways, and the transition to drug dependence. Am J Psychiatry. 2007 Aug;164(8):1149-59. doi: 10.1176/appi.ajp.2007.05030503.
Goldstein RZ, Volkow ND. Dysfunction of the prefrontal cortex in addiction: neuroimaging findings and clinical implications. Nat Rev Neurosci. 2011 Oct 20;12(11):652-69. doi: 10.1038/nrn3119.
Brower KJ. Alcohol's effects on sleep in alcoholics. Alcohol Res Health. 2001;25(2):110-25.
Conroy DA, Arnedt JT. Sleep and substance use disorders: an update. Curr Psychiatry Rep. 2014 Oct;16(10):487. doi: 10.1007/s11920-014-0487-3.
Hasler BP, Smith LJ, Cousins JC, Bootzin RR. Circadian rhythms, sleep, and substance abuse. Sleep Med Rev. 2012 Feb;16(1):67-81. doi: 10.1016/j.smrv.2011.03.004. Epub 2011 May 26.
American Psychiatric Association (2013) Diagnostic and Statistical Manual of Mental Disorders Fifth Edition. (DSM V) 361-368.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Miller WR (1996): Form 90: A structured assessment interview for drinking and related behaviors. Center for Alcoholism: Substance Abuse and Addiction, University of New Mexico, Albuquerque.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Tiffany ST, Wray JM. The clinical significance of drug craving. Ann N Y Acad Sci. 2012 Feb;1248:1-17. doi: 10.1111/j.1749-6632.2011.06298.x. Epub 2011 Dec 16.
Rush CR, Frey JM, Griffiths RR. Zaleplon and triazolam in humans: acute behavioral effects and abuse potential. Psychopharmacology (Berl). 1999 Jul;145(1):39-51. doi: 10.1007/s002130051030.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00005409
Identifier Type: -
Identifier Source: org_study_id
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