Study of Medical Treatment for Methamphetamine Addiction
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methamphetamine; Amphetamine Dependence; Pharmacogenetics; Methamphetamine Dependence; Substance Abuse
Intervention: Bupropion (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s):
Keith G Heinzerling, MD MPH, Principal Investigator, Affiliation: UCLA Dept of Family Medicine
Summary
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.
Clinical Details
Official title: Pharmacogenomics and Medication Development for Methamphetamine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Treatment Effectiveness ScoreEnd of Treatment Methamphetamine Abstinence
Secondary outcome: Treatment Retention
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 18 years of age or older;
2. meet DSM-IV criteria for methamphetamine dependence;
3. seeking treatment for MA problems;
4. specific range of methamphetamine use in the 30 days prior to study entry;
5. willing and able to comply with study procedures, including genotyping;
6. willing and able to provide written informed consent;
7. if female, not pregnant or lactating and willing to use an acceptable method of
barrier birth control (e. g. condoms) during the trial.
Exclusion Criteria:
1. have a medical condition that, in the study physician's judgment, may interfere with
safe study participation (e. g., active TB, unstable cardiac, renal, or liver disease,
unstable diabetes);
2. have a current neurological disorder (e. g., organic brain disease, dementia) or major
psychiatric disorder not due to substance abuse (e. g., schizophrenia, bipolar
disorder) as assessed by the SCID or a medical history which would make study agent
compliance difficult or which would compromise informed consent, or recent (past 30
days) history of suicide attempts and/or current serious suicidal intention or plan
as assessed by the SCID;
3. currently on prescription medication that is contraindicated for use with bupropion;
4. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined
by DSM-IV-TR;
5. have a history of alcohol dependence within the past three years;
6. have a history of a seizure disorder;
7. have a medical condition (such as serious head injury) that is associated with
increased risk of seizures or on a medication that lowers the seizure threshold;
8. have a history of anorexia or bulimia;
9. have current hypertension uncontrolled by medication, or any other circumstances
that, in the opinion of the investigators, would compromise participant safety;
10. have a history of sensitivity to bupropion.
Locations and Contacts
UCLA Clinical Research Site 910 Vine St, Los Angeles, California 90038, United States
Additional Information
UCLA Substance Abuse Pharmacotherapy Unit
Starting date: January 2009
Last updated: January 10, 2014
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