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Trial record 99 of 189 for:    BUPRENORPHINE AND NALOXONE

Comparison of Three Opioid Detoxification Treatment Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03678792
Recruitment Status : Withdrawn (Infeasible to conduct at this time.)
First Posted : September 20, 2018
Last Update Posted : November 5, 2019
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

Brief Summary:
Despite an increased focus on treating opioid use disorder there are relatively few studies that compare the length of time required for detoxification with medications other than buprenorphine. Morphine and tramadol have shorter half-lives than buprenorphine and can be used for opioid detoxification. The proposed protocol aims to address this gap by directly comparing the length of treatment required for detoxification from opioids in a patient-centered manner with oral morphine, tramadol, or buprenorphine-naloxone as well as comparing the severity of withdrawal experienced by patients in each group. The investigators predict that treatment with oral morphine or tramadol will result in a faster completion of detoxification and initiation of naltrexone maintenance.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Opioid Withdrawal Drug: Buprenorphine/naloxone Drug: Morphine Drug: Tramadol Phase 3

Detailed Description:

Opioid dependent individuals will be recruited for participation in the study. Upon recruitment into the randomized trial each participant will be started on an induction dosage of medication intended to suppress withdrawal (either buprenorphine-naloxone, morphine, or tramadol). Participants will remain on the induction dose for at least 24 hrs. Severity of withdrawal will be assessed twice a day using the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opiate Withdrawal Scale (SOWS). Each morning, participants will be given the option to progress on the tapering protocol (see below for individual regimens). Time to complete detoxification and initiation of naltrexone treatment will be measured. At completion of the study each participant will complete a 7-iten Detoxification Treatment Satisfaction questionnaire.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxone

Arm Intervention/treatment
Standard of Care
Drug: Buprenorphine/naloxone
Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day

Experimental: Morphine Drug: Morphine
Participants in this group will be tapered on an oral morphine regimen, 30-60mg/day

Experimental: Tramadol Drug: Tramadol
Participants in this group will be tapered on an oral morphine regimen, 50-100mg/day

Primary Outcome Measures :
  1. Time to detoxification regimen completion [ Time Frame: Five to twenty days ]
    Will be measured from first to last dose of tapering medication

  2. Time to naltrexone test dose [ Time Frame: 12 to 30 days ]
    Measured from first dose of tapering medication to naltrexone test dose

Secondary Outcome Measures :
  1. Subjective Opiate Withdrawal Scale [ Time Frame: Five to twenty days ]
    The Subjective Opiate Withdrawal Scale (SOWS) measures the severity of 16 symptoms of opiate withdrawal as rated by the patient on a scale of 0 (not at all) to 4 (extremely). Total scores for each patient will be recorded each day and compared between treatment groups.

  2. Clinical Opiate Withdrawal Scale [ Time Frame: Five to twenty days ]
    The Clinical Opiate Withdrawal Scale (COWS) measures the severity of 11 signs and symptoms of opiate withdrawal as rated by a healthcare provider. Each symptom is rated 0 (either no symptom or abnormal sign present) to 4 or 5 (sign or symptom is prominent or severe). Scores are considered severe if greater than 36, moderately severe if 25-36, moderate if 13-25, and mild if 5-12. Maximum score possible is 48. Total scores across treatment will be compared between treatment groups.

  3. Total use of 'as needed medications' during detoxification [ Time Frame: Five to twenty days ]
    The following medications will be available to all patients throughout the the study; gabapentin, loperamide, ondansetron, ibuprofen, and hydroxyzine. The total amount of these 'as needed' medications will be recorded and compared between the different treatment groups.

  4. Treatment Satisfaction Survey [ Time Frame: One day ]
    To assess treatment satisfaction each patient will complete a 6-question survey at the end of the study protocol. Patients will be asked to rate their satisfaction with their medication treatment, from very dissatisfied to very satisfied, how bothersome withdrawal symptoms were, from very bothersome to not at all bothersome, what if any side effects were experience, and by how much the medication reduced cravings, from not at all to completely.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-65 years of age
  • 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:

  • Use of methadone or buprenorphine exclusively
  • Pregnancy
  • Hypotensive
  • History of seizures
  • Physical dependence on alcohol and/or benzodiazepines that requires treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678792

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
University of Alabama at Birmingham

Additional Information:

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Responsible Party: Karen Cropsey, Principle Investigator, University of Alabama at Birmingham Identifier: NCT03678792     History of Changes
Other Study ID Numbers: IRB-300001612
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists