Comparison of Three Opioid Detoxification Treatment Regimens

NCT03678792 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: IRB-300001612
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders; Opioid Withdrawal

Outcome Measures

Primary Outcomes (2)

• Time to detoxification regimen completion

  Will be measured from first to last dose of tapering medication

  Five to twenty days

• Time to naltrexone test dose

  Measured from first dose of tapering medication to naltrexone test dose

  12 to 30 days

Secondary Outcomes (4)

• 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

Study Arms (3)

Buprenorphine-Naloxone

OTHER

Standard of Care

Drug: Buprenorphine/naloxone

Morphine

EXPERIMENTAL

Drug: Morphine

Tramadol

EXPERIMENTAL

Drug: Tramadol

Interventions

Buprenorphine/naloxone DRUG

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

Buprenorphine-Naloxone

Morphine DRUG

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

Morphine

Tramadol DRUG

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

Tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (12)

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  PMID: 24500948 BACKGROUND

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  PMID: 22021771 BACKGROUND

• Bukten A, Roislien J, Skurtveit S, Waal H, Gossop M, Clausen T. A day-by-day investigation of changes in criminal convictions before and after entering and leaving opioid maintenance treatment: a national cohort study. BMC Psychiatry. 2013 Oct 16;13:262. doi: 10.1186/1471-244X-13-262.

  PMID: 24131480 BACKGROUND

• Comer SD, Sullivan MA, Yu E, Rothenberg JL, Kleber HD, Kampman K, Dackis C, O'Brien CP. Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial. Arch Gen Psychiatry. 2006 Feb;63(2):210-8. doi: 10.1001/archpsyc.63.2.210.

  PMID: 16461865 BACKGROUND

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  PMID: 28068780 BACKGROUND

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  PMID: 16595358 BACKGROUND

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  PMID: 22540433 BACKGROUND

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  PMID: 12924748 BACKGROUND

• Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJ, Kanof PD. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse. 1987;13(3):293-308. doi: 10.3109/00952998709001515.

  PMID: 3687892 BACKGROUND

Related Links

• Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Morphine; Tramadol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Morphine Derivatives; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: November 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 25, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-10

Locations

US (1)