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Comparison of Three Opioid Detoxification Treatment Regimens

NCT03678792 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-11-05

No results posted yet for this study

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.

Conditions

  • Opioid-Related Disorders
  • Opioid Withdrawal

Interventions

DRUG

Buprenorphine/naloxone

Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day

DRUG

Morphine

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

DRUG

Tramadol

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2020-09-30
Completion
2020-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678792 on ClinicalTrials.gov