Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135785
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Effectiveness of Bupropion Combined With Behavioral Therapy for Treating Methamphetamine Dependence - 2
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the brain The purpose of this study is to determine the effectiveness of bupropion in combination with behavioral therapy for the treatment of methamphetamine addiction
Detailed Description:
Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and norepinephrine to be released into the brain This overload produces unusual alertness and feelings of elation When the body undergoes methamphetamine withdrawal it experiences a reduction in dopamine and norepinephrine Bupropion is an antidepressant used for the treatment of depression and smoking cessation Because it functions by increasing the release of dopamine and norepinephrine in the brain bupropion is likely to decrease the negative effects of methamphetamine withdrawal The purpose of this study is to evaluate the efficacy of bupropion combined with contingency management CM and cognitive behavioral counseling CBT as a means of treating methamphetamine dependence
An initial 2-week screening process will involve participants providing urine samples and completing physical and psychological assessments If deemed eligible for the remainder of this double-blind study participants will be randomly assigned to receive either bupropion or placebo over the course of 12 weeks Participants in both the bupropion and placebo groups will receive contingency management and cognitive behavioral counseling Participants will report to one of two clinical research sites three times per week At each visit participants will be examined by the study staff provide a urine sample and receive individual cognitive behavioral counseling sessions At the end of 12 weeks treatment will be stopped Participants will return to the study site 30 days later for evaluation and to be assessed for any possible lingering side effects
An initial 2-week screening process will involve participants providing urine samples and completing physical and psychological assessments If deemed eligible for the remainder of this double-blind study participants will be randomly assigned to receive either bupropion or placebo over the course of 12 weeks Participants in both the bupropion and placebo groups will receive contingency management and cognitive behavioral counseling Participants will report to one of two clinical research sites three times per week At each visit participants will be examined by the study staff provide a urine sample and receive individual cognitive behavioral counseling sessions At the end of 12 weeks treatment will be stopped Participants will return to the study site 30 days later for evaluation and to be assessed for any possible lingering side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| P50-DA018185-2 | None | None | None |