NCT00000354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1996

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1997

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 1996

Enrollment Period

1.2 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

opiate dependence

Interventions

LofexidineDRUG

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Charles O'Brien, M.D., Ph.D.

    PDVAMC Treatment Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

July 1, 1996

Primary Completion

September 1, 1997

Study Completion

December 1, 1997

Last Updated

January 12, 2017

Record last verified: 1996-07

Locations

US(1)