Clinical Trial: Study of Medical Treatment for Methamphetamine Addiction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pharmacogenomics and Medication Development for Methamphetamine Dependence
Brief 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 respo
Detailed Summary:
Sponsor: University of California, Los Angeles
Current Primary Outcome:
- Treatment Effectiveness Score [ Time Frame: 12 weeks ]The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)
- End of Treatment Methamphetamine Abstinence [ Time Frame: 12 weeks ]Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)
Original Primary Outcome: Clinical phenotype of frequency of baseline MA use in 30 days preceding the baseline period using self-report and results of thrice weekly urine drug screens for MA metabolites during baseline. [ Time Frame: Weekly ]
Current Secondary Outcome: Treatment Retention [ Time Frame: 12 weeks ]
Original Secondary Outcome: Clinical phenotype of treatment response to bupropion on MA use during the medication phase, as measured via self-reported MA use and thrice weekly urine screens for MA metabolites. [ Time Frame: 12 weeks ]
Information By: University of California, Los Angeles
Dates:
Date Received: January 30, 2009
Date Started: January 2009
Date Completion:
Last Updated: January 10, 2014
Last Verified: January 2014
