NCT02801357

Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

A Phase 1 Study to Evaluate the Relative Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: USWM, LLC (dba US WorldMeds) · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.

Detailed description

This is a Phase 1, open-label, inpatient study in male and female subjects seeking at least a 4 mg reduction of their buprenorphine maintenance dose. The purpose of this study is to assess the relative exposures of lofexidine and its 3 major metabolites in subjects tapering from buprenorphine maintenance treatment. Lofexidine is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.

Conditions

• Substance Withdrawal Syndrome
• Opiate Addiction
• Opiate Dependence

Interventions

Type	Name	Description
DRUG	lofexidine administration in subjects seeking buprenorphine dose reduction

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-06-15
• Last updated: 2017-10-26

Locations

1 site across 1 country: United States