Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients

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.

Conditions

• Opioid Dependence
• Buprenorphine Withdrawal Syndrome

Interventions

DRUG

Lofexidine HCl

Lofexidine HCl tablets titrated in ascending doses of 0.2 mg (1 tablet) QID starting at 0.4 mg (2 tablets) QID \[e.g. Day 1 0.4 mg (2 tablets) QID, Day 2 0.6 mg (3 tablets) QID, etc.\] as described in the treatment arm. Option to down-titrate to 0.2 mg (1 tablet) QID if 0.4 mg (2 tablets) QID dose not initially tolerated.

DRUG

Lofexidine-matching sugar pill

Lofexidine-matching sugar pill tablets titrated in ascending doses of 1 tablet starting at 2 tablets QID (e.g. Day 1 2 tablets QID, Day 2 3 tablets QID, etc.) as described in the treatment arm. Option to down-titrate to 1 tablet QID if 2 tablets not initially tolerated.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• USWM, LLC (dba US WorldMeds)

  lead INDUSTRY

Principal Investigators

• Charles W Gorodetzky, MD, PhD · US WorldMeds

• James A Longstreth, PhD · US WorldMeds

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States

Study Locations