Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess lofexidine related effects on QTc (an
interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary
objectives of the study are to evaluate the safety and tolerability of lofexidine by
evaluating and monitoring pharmacokinetics (amounts of drug in the blood), vital signs (heart
rate and blood pressure) and adverse events (side effects) when co-administered with
buprenorphine; to describe effects on opiate withdrawal when lofexidine is introduced
following a 50% buprenorphine dose reduction, as required to elicit a withdrawal response;
and to evaluate QTc interaction effects of lofexidine compared with placebo. The
Investigators hypothesize that while lofexidine is known to prolong the QTc interval, the
combination of the drugs will not create an additive effect which creates a significant
safety concern. The Investigators further hypothesize that subjects will be able to tolerate
the therapeutic dose of lofexidine (0.8 mg four times daily) when the buprenorphine
maintenance dose is lowered to elicit withdrawal.