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Completed

NCT Number: NCT00032942

Lofexidine for Opiate Withdrawal - 1

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

Completed

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCLA Medical Center, Los Angeles, California, United States

Loading trial locations.

About this study

An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Additional criteria available during screening at the site

Treatment and study plan

Lofexidine

Drug

Primary outcomes

  1. Opiate withdrawal symptoms

  2. Potential Abuse Liability

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Britannia Pharmaceuticals Ltd.

Registry information

Official study title

A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal

Important dates

Study start
2001
Primary completion
2004
First posted
Apr 8, 2002
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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