Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323837
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-05
Brief Title:
Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
Sponsor:
Washington State University
Organization:
Washington State University
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo-controlled Clinical Trial RCT to Evaluate the Ability of Mirtazapine MZP to Increase Methamphetamine MA Abstinence Among Treatment-seeking Medication for Opioid Use Disorder MOUD Adults
Status:
RECRUITING
Status Verified Date:
2024-08
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:
MIRROM
Brief Summary:
This project will evaluate the ability of Mirtazapine MZP a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine MA use among medication for opioid use disorder MOUD patients to significantly decrease MA use and related health-impairing behaviors MZP has already successfully been used in the treatment of methamphetamine detailed further below and in the Appendices
The investigators hypothesize that those assigned to the MZP plus treatment as usual TAU MZPTAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo PLOTAU arm across the 10-week treatment and follow-up periods
The investigators hypothesize that those assigned to the MZP plus treatment as usual TAU MZPTAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo PLOTAU arm across the 10-week treatment and follow-up periods
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None