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NCT01188421 · ClinicalTrials.gov registry record · Phase 1

Medications Development for Drug Abuse Disorders

A Phase 1 study of Opioid-Related Disorders and Opioid Dependence, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 1
Development phase
106
Enrollment target
1
Study location

NCT01188421 is a Phase 1 study of Opioid-Related Disorders and Opioid Dependence that has completed, run by Johns Hopkins University. The registered enrollment target is 106 participants, below the 345-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01188421, a Phase 1 study of Opioid-Related Disorders and Opioid Dependence, has completed, sponsored by Johns Hopkins University.

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

Study Summary

This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.

Interventions

  • DRUG Buprenorphine/naloxone
  • DRUG Clonidine
  • DRUG Tramadol ER

Study Locations (1)

Maryland

  • Johns Hopkins University (BPRU) Bayview Campus - Baltimore

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2010-10
Est. Completion 2015-06
Phase Phase 1

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT01188421

The ClinicalTrials.gov registry entry for NCT01188421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (69% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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

NCT01188421 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01188421 about?

NCT01188421 is a clinical study titled "Medications Development for Drug Abuse Disorders". This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants...

What is the current status of trial NCT01188421?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2010-10. Estimated completion is 2015-06.

What conditions does trial NCT01188421 study?

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

What interventions are being tested in trial NCT01188421?

The interventions under investigation include: Buprenorphine/naloxone (DRUG), Clonidine (DRUG), Tramadol ER (DRUG).

Who is sponsoring clinical trial NCT01188421?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01188421 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.