Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10

Opioid-Related Disorders Clinical Trial

Official title:

Evaluation of Lofexidine for Treatment of Opiate Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000345
• Other study ID #: NIDA-3-0010-10
• Secondary ID: Y01-3-0010-10
• Status: Completed
• Phase: Phase 1
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: April 1996

Study information

• Verified date: September 1997
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety of lofexidine in the treatment of opiate-dependent individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Lofexidine

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate withdrawal
Primary	Adverse effect measures
Primary	Craving of opiates
Primary	Liking of opiates
Primary	Efficacy of lofexidine
Primary	Euphoria