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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Opioid DependenceBuprenorphine 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.

Trial Locations (1)

84106

Lifetree Clinical Research, Salt Lake City

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

USWM, LLC (dba US WorldMeds)

INDUSTRY

NCT01820442 - Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients | Biotech Hunter | Biotech Hunter