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NCT00637000 · ClinicalTrials.gov registry record · Phase 2

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

A Phase 2 study of Opioid-Related Disorders, sponsored by Indivior.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
1
Study location

NCT00637000 is a Phase 2 study of Opioid-Related Disorders that has completed, run by Indivior. The registered enrollment target is 38 participants, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00637000, a Phase 2 study of Opioid-Related Disorders, has completed, sponsored by Indivior.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Buprenorphine soluble film
  • DRUG Buprenorphine/naloxone film strip

Study Locations (1)

Maryland

  • Johns Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2008-03
Est. Completion 2008-09
Phase Phase 2

Sponsor

Indivior

37 total trials

What the Registry Record Tells You About NCT00637000

The ClinicalTrials.gov registry entry for NCT00637000 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 346-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (89% lower). The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00637000 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00637000 about?

NCT00637000 is a clinical study titled "Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone". The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of with...

What is the current status of trial NCT00637000?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2008-03. Estimated completion is 2008-09.

What conditions does trial NCT00637000 study?

This clinical trial studies the following conditions: Opioid-Related Disorders.

What interventions are being tested in trial NCT00637000?

The interventions under investigation include: Placebo (DRUG), Buprenorphine soluble film (DRUG), Buprenorphine/naloxone film strip (DRUG).

Who is sponsoring clinical trial NCT00637000?

This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00637000 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.