Name of Project: CTO: Double-blind, Placebo-controlled,
Dose-response Trial of Ondansetron for the Treatment of Methamphetamine
Principal Investigator: Thomas Newton, M.D.
Co-Principal Investigators: Richard Rawson, Ph.D., and Walter Ling, M.D.
Project Director: Valerie Pearce
Funding Agency: National Institute on Drug Abuse
(NIDA)
Funding Period: February 2000-February 2005
Scope of Project: The NIDA Methamphetamine Clinical
Trials Operations (CTO) group involves the establishment of five
clinical
research sites coordinated by UCLA researchers where medications
with potential value for methamphetamine users will be tested.
The goal of this network is to speed the development of methamphetamine
pharmacotherapy research by establishing multiple research clinics
in
geographic regions of the United States with substantial methamphetamine
(MA) problems. The ondansetron protocol is currently being conducted
by investigators associated with six organizations: the University
of Texas Health Science Center, San Antonio, Texas; University
of Missouri-Kansas City, Kansas City, Missouri; University of
Hawaii (Queens Hospital) Honolulu, Hawaii; Friends Research Institute
(Matrix Institute on Addictions), Costa Mesa, California; South
Bay Treatment Center, San Diego, California; and the Iowa Health
Systems (Powell Chemical Dependency Center, Lutheran Hospital),
Des Moines, Iowa. This study is a preliminary assessment of the
efficacy and safety of three wide range doses of ondansetron (0.25,
1.0, and 4.0 mg taken orally twice per day) to reduce methamphetamine
use in subjects with methamphetamine dependence and to determine
the optimal dose of ondansetron. It is hypothesized that ondansetron
treatment, compared to placebo, will be associated with a decrease
in methamphetamine use as measured by quantitative urinalysis
for methamphetamine. This is a double-blind, placebocontrolled,
randomized, four arm dose-ranging study comparing three dose levels
of ondansetron to placebo administered to methamphetamine-dependent
outpatients. All subjects will receive a base of standardized,
manual-driven cognitive behavioral therapy (a 90-minute group
session thrice weekly) over eight weeks of treatment. A final
follow-up assessment will be conducted four weeks after completion
of treatment.
For more information, contact Thomas
Newton.
Last updated - 08/07/2003
Last reviewed - 08/4/03