Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497081
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2007-07-05
Brief Title:
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Sponsor:
San Francisco Department of Public Health
Organization:
San Francisco Department of Public Health
Study Overview
Official Title:
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Studies demonstrate that methamphetamine meth use is associated with high-risk sexual behavior among MSM putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV This study of intermediate size 60 participants and length 3 months of follow-up will assess the efficacy of mirtazapine in reducing methamphetamine use among high-risk MSM
Detailed Description:
Methamphetamine use is especially prevalent among men who have sex with men MSM Population-based surveys report methamphetamine use rates 20 times higher among MSM compared with the general population Methamphetamine use is also a driving force in the MSM HIV epidemic methamphetamine use has been associated with increased number of sexual partners unprotected sex acts and sexually transmitted infection STI and HIV acquisition Despite these alarming data relatively few interventions have been tested among methamphetamine-using MSM and no studies have tested the efficacy of pharmacologic interventions in reducing methamphetamine use in this population In parallel with the continued testing of behavioral approaches we believe the time has come to test pharmacologic interventions to reduce methamphetamine use among MSM Pharmacologic approaches to treating substance use have been successful in treating nicotine alcohol and heroin dependence No studies have tested a pharmacologic intervention to reduce methamphetamine use among MSM at high risk for HIV acquisition and transmission A recent pilot study found that mirtazapine a drug with dual dopaminergic and serotonergic properties significantly reduced methamphetamine withdrawal symptoms when compared to placebo over a two-week period among Thai men in a drug probation center Mirtazapine is a commonly used FDA-approved antidepressant however in the Thai study its effects on methamphetamine withdrawal were independent of its effects on depressive symptoms suggesting a direct effect of mirtazapine on treating methamphetamine dependence We propose to expand upon these promising pilot results by conducting a study of intermediate size 60 participants and length 3 months of follow-up to assess the efficacy of mirtazapine in reducing methamphetamine use among high-risk MSM
The specific aims of our study are
1 To test the hypothesis that mirtazapine 30 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent MSM as determined by the proportion of methamphetamine-negative urines and by self-report of methamphetamine use in the mirtazapine versus placebo group
2 To measure the acceptability of mirtazapine and placebo among methamphetamine-dependent MSM by determining via electronic pill caps and self-report medication adherence to mirtazapine and placebo
3 To measure the safety and tolerability of mirtazapine and placebo among methamphetamine-dependent MSM as determined by the number of adverse clinical events in the mirtazapine and placebo arms
If promising study results will be used to design a phase III clinical trial to determine if mirtazapines effects on reducing methamphetamine use lead to reductions in methamphetamine-associated sexual risk We have chosen first to conduct a 3-year intermediate-sized trial in order to determine if mirtazapine reduces methamphetamine use and whether mirtazapine demonstrates good acceptability and tolerability among a population with methamphetamine-associated high-risk sexual behaviors If this proves to be the case we believe our study results will provide strong support for a much larger trial to test the hypothesis that mirtazapine-driven reductions in methamphetamine use will result in corresponding decreases in sexual risk behavior This study is therefore designed to reflect the structure of a larger HIV-risk reduction trial and includes both substance use and sexual risk behavior measures We will enroll sexually active methamphetamine-dependent MSM either HIV-negative or HIV-positive who will be randomized 11 to receive mirtazapine or placebo for 90 days Because no medications have been approved to treat methamphetamine dependence we include extensive safety parameters as is required by the Food and Drug Administration FDA when testing a medication for a new indication in a new population Participants will be seen weekly for urine drug testing and for brief substance use counseling All will receive HIV risk-reduction counseling Behavior will be assessed using standardized measures via audio computer-assisted self-interview ACASI
The specific aims of our study are
1 To test the hypothesis that mirtazapine 30 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent MSM as determined by the proportion of methamphetamine-negative urines and by self-report of methamphetamine use in the mirtazapine versus placebo group
2 To measure the acceptability of mirtazapine and placebo among methamphetamine-dependent MSM by determining via electronic pill caps and self-report medication adherence to mirtazapine and placebo
3 To measure the safety and tolerability of mirtazapine and placebo among methamphetamine-dependent MSM as determined by the number of adverse clinical events in the mirtazapine and placebo arms
If promising study results will be used to design a phase III clinical trial to determine if mirtazapines effects on reducing methamphetamine use lead to reductions in methamphetamine-associated sexual risk We have chosen first to conduct a 3-year intermediate-sized trial in order to determine if mirtazapine reduces methamphetamine use and whether mirtazapine demonstrates good acceptability and tolerability among a population with methamphetamine-associated high-risk sexual behaviors If this proves to be the case we believe our study results will provide strong support for a much larger trial to test the hypothesis that mirtazapine-driven reductions in methamphetamine use will result in corresponding decreases in sexual risk behavior This study is therefore designed to reflect the structure of a larger HIV-risk reduction trial and includes both substance use and sexual risk behavior measures We will enroll sexually active methamphetamine-dependent MSM either HIV-negative or HIV-positive who will be randomized 11 to receive mirtazapine or placebo for 90 days Because no medications have been approved to treat methamphetamine dependence we include extensive safety parameters as is required by the Food and Drug Administration FDA when testing a medication for a new indication in a new population Participants will be seen weekly for urine drug testing and for brief substance use counseling All will receive HIV risk-reduction counseling Behavior will be assessed using standardized measures via audio computer-assisted self-interview ACASI
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 | OTHER | NIDA | httpsreporternihgovquickSearch1R01DA022155-01 |
| R01DA022155 | NIH | None | None |
| 1R01DA022155-01 | NIH | None | None |