Comparison of Three Opioid Detoxification Treatment Regimens
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/27/2019 |
| Start Date: | April 1, 2019 |
| End Date: | November 2020 |
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.
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.
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.
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.
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
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