Name of Project: Double-blind, Placebo-controlled
Assessment of Potential Interactions Between Intravenous Methamphetamine
and Oral Bupropion
Principal Investigator: Thomas Newton, M.D.
Project Director: Nicolette van Sluis, M.A.
Funding Agency: National Institute on Drug Abuse
(NIDA)
Funding Period: February 2000-February 2005
Scope of Project: This is a human laboratory
clinical pharmacology study to assess potential interactions between
intravenous methamphetamine challenge and treatment with oral
sustained-release bupropion. The primary aim is to assess safety
prior to undertaking an outpatient clinical trial of bupropion
for the treatment of methamphetamine dependence. This is a double-blind
inpatient study in which, after establishing eligibility, subjects
will be randomized (stratified by site) into one of two treatment
groups (placebo [n = 10] or bupropion [n = 10]). All subjects
will undergo one series (baseline challenges) of intravenous methamphetamine
challenges (0, 15, and 30 mg) before placebo or bupropion administration
and a second methamphetamine challenge series (0, 15, and 30 mg)
starting six days after the initiation of the twicedaily placebo
or bupropion administration (treatment challenges). The order
of the 0 and 15 mg challenge sessions will be randomly assigned.
Thus, the investigator will only be unblind to the 30 mg methamphetamine
challenge. The 30 mg challenge will always follow the 0 and 15
mg challenge. After clinic discharge, all subjects will be asked
to return weekly for two weeks for safety follow-ups.
For more information, contact Thomas
Newton.
Last updated - 07/29/2003
Last reviewed - 07/28/3003