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Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

Primary Purpose

Opioid-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lofexidine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Please contact site for information.

Sites / Locations

  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00000358
Brief Title
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7
Official Title
Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Pennsylvania

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lofexidine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles O'Brien, M.D., Ph.D.
Organizational Affiliation
PDVAMC Treatment Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

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