Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Opioid-Related Disorders
Interventions
DRUG

Lofexidine

Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.

DRUG

Placebo

Lofexidine Placebo

Trial Locations (1)

06519

Yale University, Psychiatry, New Haven

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Yale University

OTHER

NCT00142909 - Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1 | Biotech Hunter | Biotech Hunter