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NCT00032942 Clinical Trial

Lofexidine for Opiate Withdrawal - 1

Opioid-Related Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00032942
Other study ID # NIDA-CSP-1020-1
Secondary ID
Status Completed
Phase Phase 3
First received April 5, 2002
Last updated January 11, 2017
Start date April 2001

Study information
Verified date July 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers
  • NCT00007566
  • NCT00024713

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lofexidine

Locations
Country Name City State
United States UCLA Medical Center Los Angeles California
United States Columbia University New York New York
United States Philadelphia Veterans Medical Center Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) Britannia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opiate withdrawal symptoms
Primary Potential Abuse Liability
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