Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888835
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2013-06-25
Brief Title:
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM M20
Sponsor:
Phillip Coffin MD MIA
Organization:
San Francisco Department of Public Health
Study Overview
Official Title:
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM a 6-month Randomized Controlled Trial With 3 Months of Follow-up
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The investigators recently conducted a double-blind randomized controlled trial n60 of limited duration 12 weeks and found that compared with placebo oral mirtazapine an FDA-approved antidepressant significantly reduced meth use in those receiving mirtazapine as determined by reduction in meth-positive urines Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo Mirtazapine decreased meth use despite low adherence by medical event monitoring system MEMS caps only 485 of daily doses were taken All participants received weekly substance use counseling and monthly brief clinician-delivered adherence counseling The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks with adherence reminders added to the counseling and determining if efficacy is sustained up to 12 weeks after drug discontinuation The sample size for this 9-month study is 120
Detailed Description:
None
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 |
|---|---|---|---|
| R01DA034527 | NIH | None | httpsreporternihgovquickSearchR01DA034527 |