Substance Abuse Clinical Trial
Official title:
Pharmacogenomics and Medication Development for Methamphetamine Dependence
Currently there are no medications approved for the treatment of methamphetamine addiction.
Bupropion is an antidepressant that is approved by the Food and Drug Administration (FDA)
for the treatment of depression and for cigarette smoking cessation but is not approved by
the FDA for the treatment of methamphetamine addiction. Preliminary research studies suggest
that bupropion may help people receiving treatment for methamphetamine addiction to reduce
or to stop their methamphetamine use. But results of these studies also suggest that
bupropion may help certain groups of patients more than others, such as men versus women and
light versus heavy methamphetamine users, although the reasons for this difference are not
known. One possibility is that a person's genetic make up may influence whether or not they
respond to treatment with bupropion for methamphetamine addiction.
The purpose of the study is to determine if bupropion is can help people reduce or stop
their methamphetamine use and to investigate whether genetic variations influence whether
people respond to treatment with bupropion for methamphetamine addiction, which may help
doctors and patients better decide if treatment with bupropion will be beneficial or not. To
identify possible genetic variations that influence response to bupropion, we will perform
genetic tests on blood or saliva specimens from participants receiving treatment with either
bupropion or placebo (which is a pill that contains no medication) in conjunction with
standard cognitive behavioral therapy drug counseling. We will compare methamphetamine use,
as assessed with urine drug screens, among participants receiving bupropion versus those
receiving placebo to determine if bupropion helps people to reduce or stop their
methamphetamine use. We will then compare the results of the genetic tests among
participants who respond and who do not respond to bupropion. In addition, since the amount
of methamphetamine a person uses was associated with response to bupropion in preliminary
studies, we will also compare the results of genetic testing among persons with heavy versus
light methamphetamine use before entering treatment.
Results of this study have the potential to provide insights into the biology of
methamphetamine addiction and help increase the understanding of how bupropion works. This
information could be useful to develop effective medications for methamphetamine addiction
and to improve the ability of clinicians to provide treatment to patients with
methamphetamine addiction.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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