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Lofexidine for Opiate Withdrawal - 1

Phase 3
Completed
Conditions
Opioid-Related Disorders
Registration Number
NCT00032942
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Opiate withdrawal symptoms
Potential Abuse Liability
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Philadelphia Veterans Medical Center

🇺🇸

Philadelphia, Pennsylvania, United States

UCLA Medical Center

🇺🇸

Los Angeles, California, United States

Columbia University

🇺🇸

New York, New York, United States

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