Comparison of Three Opioid Detoxification Treatment Regimens

October 31, 2019 updated by: Karen Cropsey, University of Alabama at Birmingham

Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morphine
Drug: Morphine
Participants in this group will be tapered on an oral morphine regimen, 30-60mg/day
Other: Buprenorphine-Naloxone
Standard of Care
Drug: Buprenorphine/naloxone
Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day
Experimental: Tramadol
Drug: Tramadol
Participants in this group will be tapered on an oral morphine regimen, 50-100mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to detoxification regimen completion
Time Frame: Five to twenty days
Will be measured from first to last dose of tapering medication
Five to twenty days
Time to naltrexone test dose
Time Frame: 12 to 30 days
Measured from first dose of tapering medication to naltrexone test dose
12 to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five to twenty days
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.
Five to twenty days
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.
Five to twenty days
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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 25, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300001612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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