NCT00032942

Brief Summary

The purpose of this study is to evaluate lofexidine for opiate withdrawal.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 2008

Enrollment Period

3.5 years

First QC Date

April 5, 2002

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

opiate dependence

Outcome Measures

Primary Outcomes (2)

  • Opiate withdrawal symptoms

  • Potential Abuse Liability

Interventions

LofexidineDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female as least 18 yrs of age \& above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

You may not qualify if:

  • Additional criteria available during screening at the site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Columbia University

New York, New York, 10023, United States

Location

Philadelphia Veterans Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

lofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ann Montgomery, R.N.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

April 1, 2001

Primary Completion

October 1, 2004

Last Updated

January 12, 2017

Record last verified: 2008-07

Locations

US(3)