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Lofexidine for Inpatient Opiate Detox

NCT00235729 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2009-03-20

No results posted yet for this study

Summary

The main objective of this study is to investigate the effectiveness of lofexidine in reducing withdrawal symptoms among subjects undergoing opiate detoxification. Currently, lofexidine is the most commonly used non-opiate medication for detoxification from opiates in the United Kingdom (UK). There is no non-opiate medication approved by the Food and Drug Administration (FDA) for the same indication in the United States (US). The only medications currently approved by the FDA for opiate detoxification are methadone and buprenorphine. These medications, however, have the potential to be abused. Lofexidine, on the other hand, offers a unique advantage for opiate detoxification because it is not addicting, is easy to use, and has a favorable safety profile.

Conditions

  • Opiate Addiction

Interventions

DRUG

Lofexidine

Lofexidine is an alpha2-adrenergic-agonist with mild to moderate antihypertensive actions. It is mainly used in the alleviation of opioid withdrawal signs and symptoms.

DRUG

Placebo

Placebo is an exact match of lofexidine, less the active ingredient.

Sponsors & Collaborators

Principal Investigators

  • Charles W. Gorodetzky · VA Maryland Health Care System, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00235729 on ClinicalTrials.gov