Comparison of Three Opioid Detoxification Treatment Regimens
NCT ID: NCT03678792
Last Updated: 2019-11-05
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
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-11-15
2020-10-25
Brief Summary
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Detailed Description
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Taper Schedule Dosing Buprenorphine-Naloxone (Suboxone): Patients will get 4mg when withdrawal symptoms start. Patients can receive the first 8mg dose as early as 6hrs later, and at that point will start on an 8mg twice-a-day schedule. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Buprenorphine-naloxone will be tapered 2mg/day.
Tramadol: At enrollment the patients will receive a 100mg dose and can receive another 100mg every 6 hrs for 24 hrs. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Patients will then be tapered on the following schedule 100mg every 8 hrs, 50mg every 6 hrs, 50mg every 8 hrs, 50mg ever 12 hrs, and one final daily dose of 50mg.
Morphine: Patients receive 30mg every 4 hours for 24 hrs from when withdrawal symptoms start. Each morning the patient will be assessed regarding their ability to progress to the next stage of the taper. Patients will then be tapered on the following schedule: 30 mg every 6 hours, 30 mg every 8 hours, 30 mg every 12 hours, and one final daily 30 mg dose.
As Needed Medications: Patients in all groups will have access to the following medications as needed gabapentin 400mg every 8 hrs, loperamide 2mg every 3 hrs, odansetron 4mg every 6 hrs, ibuprofen 600mg ever 8 hrs, and hydroxyzine 25-50mg nightly.
Naltrexone Test Dose Patients will receive an oral test dose of naltrexone (25mg) either 10 days after completing the buprenorphine-naloxone taper (standard of care) or 7 days after the morphine or tramadol taper. If the oral test dose is tolerated then the patients may choose to pursue treatment with an extended release naltrexone intramuscular injection (380mg) 24 hrs later. Due to the risk for hepatocellular injury with naltrexone, patients with baseline elevations in either aspartate transaminase or alanine transaminase greater than three times the upper limit of our clinical laboratory's reference range will be ineligible to receive extended release naltrexone, but may choose to continue oral naltrexone maintenance therapy (50mg daily) (standard of care). As part of the study the investigators will record the time to naltrexone maintenance therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Buprenorphine-Naloxone
Standard of Care
Buprenorphine/naloxone
Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day
Morphine
Morphine
Participants in this group will be tapered on an oral morphine regimen, 30-60mg/day
Tramadol
Tramadol
Participants in this group will be tapered on an oral morphine regimen, 50-100mg/day
Interventions
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Buprenorphine/naloxone
Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day
Morphine
Participants in this group will be tapered on an oral morphine regimen, 30-60mg/day
Tramadol
Participants in this group will be tapered on an oral morphine regimen, 50-100mg/day
Eligibility Criteria
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Inclusion Criteria
* Meeting DSM-V criteria for opioid use disorder
* Current use of opiates
* Displaying evidence of opioid withdrawal
* Having no significant current medical/psychiatric illness
* English speaking
Exclusion Criteria
* Pregnancy
* Hypotensive
* History of seizures
* Physical dependence on alcohol and/or benzodiazepines that requires treatment
18 Years
65 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Karen Cropsey
Principle Investigator
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
Jiang R, Lee I, Lee TA, Pickard AS. The societal cost of heroin use disorder in the United States. PLoS One. 2017 May 30;12(5):e0177323. doi: 10.1371/journal.pone.0177323. eCollection 2017.
Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD002207. doi: 10.1002/14651858.CD002207.pub4.
Skeie I, Brekke M, Gossop M, Lindbaek M, Reinertsen E, Thoresen M, Waal H. Changes in somatic disease incidents during opioid maintenance treatment: results from a Norwegian cohort study. BMJ Open. 2011 Aug 6;1(1):e000130. doi: 10.1136/bmjopen-2011-000130.
Bukten A, Roislien J, Skurtveit S, Waal H, Gossop M, Clausen T. A day-by-day investigation of changes in criminal convictions before and after entering and leaving opioid maintenance treatment: a national cohort study. BMC Psychiatry. 2013 Oct 16;13:262. doi: 10.1186/1471-244X-13-262.
Comer SD, Sullivan MA, Yu E, Rothenberg JL, Kleber HD, Kampman K, Dackis C, O'Brien CP. Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial. Arch Gen Psychiatry. 2006 Feb;63(2):210-8. doi: 10.1001/archpsyc.63.2.210.
Sullivan M, Bisaga A, Pavlicova M, Choi CJ, Mishlen K, Carpenter KM, Levin FR, Dakwar E, Mariani JJ, Nunes EV. Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine. Am J Psychiatry. 2017 May 1;174(5):459-467. doi: 10.1176/appi.ajp.2016.16050548. Epub 2017 Jan 10.
Fishbain DA, Rosomoff HL, Cutler R. Opiate detoxification protocols. A clinical manual. Ann Clin Psychiatry. 1993 Mar;5(1):53-65. doi: 10.3109/10401239309148924.
Threlkeld M, Parran TV, Adelman CA, Grey SF, Yu J. Tramadol versus buprenorphine for the management of acute heroin withdrawal: a retrospective matched cohort controlled study. Am J Addict. 2006 Mar-Apr;15(2):186-91. doi: 10.1080/10550490500528712.
Zarghami M, Masoum B, Shiran MR. Tramadol versus methadone for treatment of opiate withdrawal: a double-blind, randomized, clinical trial. J Addict Dis. 2012;31(2):112-7. doi: 10.1080/10550887.2012.665728.
Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.
Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJ, Kanof PD. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse. 1987;13(3):293-308. doi: 10.3109/00952998709001515.
Related Links
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Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health
Other Identifiers
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IRB-300001612
Identifier Type: -
Identifier Source: org_study_id
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