Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Time to detoxification regimen completion
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Buprenorphine-Naloxone
Standard of Care
Intervention: Buprenorphine/naloxone (Drug)
Morphine
Intervention: Morphine (Drug)
Tramadol
Intervention: Tramadol (Drug)
Outcomes
Primary Outcomes
Time to detoxification regimen completion
Time Frame: Five to twenty days
Will be measured from first to last dose of tapering medication
Time to naltrexone test dose
Time Frame: 12 to 30 days
Measured from first dose of tapering medication to naltrexone test dose
Secondary Outcomes
- Subjective Opiate Withdrawal Scale(Five to twenty days)
- Clinical Opiate Withdrawal Scale(Five to twenty days)
- Total use of 'as needed medications' during detoxification(Five to twenty days)
- Treatment Satisfaction Survey(One day)
Investigators
Karen Cropsey
Principle Investigator
University of Alabama at Birmingham