ISAP Research Projects
Name of Project: Gabapentin and Baclofen for
Treating Methamphetamine Dependence
Principal Investigator: Steven Shoptaw, Ph.D.
Project Director: James Peck, Psy.D.
Funding Agency: National Institute on Drug Abuse
(NIDA)
Funding Period: September 1999-August 2004
Scope of Project: This project seeks to evaluate
the efficacy of two medications (gabapentin and baclofen) compared
to placebo in treating methamphetamine dependence. These medications
are being studied in conjunction with a base of standardized,
manual-driven psychosocial relapse prevention drug counseling
(Matrix Model) in 120 methamphetamine-dependent individuals. The
project features a three-parallel group design with two active
medication conditions and a common placebo. Participants are randomly
assigned to one of three conditions: (1) gabapentin (n = 35),
(2) baclofen (n = 35), or (3) placebo (n = 50), using an urn randomization
procedure. The main questions of interest in this rapid screening
protocol is whether participants who are randomly assigned to
either active medication arm have better outcomes than participants
assigned to receive placebo. Comparison of medication conditions
with each other are of no interest, since the purpose is to identify,
as rapidly as possible, medications with sufficient promise to
commit further resources for a larger sample in a multisite trial.
The primary advantage of the common placebo is that it substantially
reduces the number of participants needed to evaluate the active
medication arms. The common placebo also minimizes historical
threats that can occur from changes in drug-use trends during
a series of studies.
For more information, contact Steven
Shoptaw.
Last updated - 04/09/04
Last reviewed - 04/02/04