Name of Project: Suboxone (Buprenorphine/Naloxone)
Taper: A Comparison of Two Schedules
Principal Investigator: Walter Ling, M.D.
Co-Principal Investigator: Andrew Saxon, M.D
Project Director: Jerry Cunningham-Rathner
Funding Agency: National Institute on Drug Addiction
(NIDA)
Funding Period: June 2003-December 2005
Scope of Project: This study aims to compare,
in the outpatient setting, the relative advantage of two taper
schedules (7 vs. 28 days) of Suboxone (buprenorphine-naloxone)
following four weeks of Suboxone stabilization. It is hypothesized
that a more gradual taper schedule compared to a shorter one will
result in lower rates of illicit opiate use (as reflected by urine
toxicology tests) at the end of the taper. However, there may
be an interaction between the rate of taper and the stabilization
dose. The proportion of participants providing opiate free urines
in each group will be compared at the end of the taper, as well
as at other time points (i.e. at 1 and 3 months post taper). Safety,
as reflected by Adverse Events (AEs) and Severe Adverse Events
(SAEs), withdrawal severity, stabilization dose and treatment
retention during the study will also be explored. This is a randomized,
open-label, parallel-group design study.The duration of study
participation for each participant will be a maximum of approximately
5 months, including screening, stabilization, tapering, post-tapering
and follow-up. Results from this study will add to the knowledge
base of the clinical use of Suboxone and provide clinicians with
data to guide the process of tapering from Suboxone treatment
after a period of stabilization.
For more information, contact Walter
Ling.
Last updated - 07/29/2003
Last reviewed - 07/25/2003