Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride,
an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from
short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind
treatment portion where subjects will be randomly assigned to one of three doses of study
medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or
placebo) followed by an optional open-label treatment period where subjects will be inpatient
or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The
Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable
side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily
doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.