Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-30 @ 3:28 AM
Study NCT ID:
NCT03336866
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Antibody for Methamphetamine Outpatient Therapy
Sponsor:
InterveXion Therapeutics, LLC
Organization:
Study Overview
Official Title:
STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy
Status:
COMPLETED
Status Verified Date:
2022-01
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:
STAMPOUT
Brief Summary:
This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses.
Detailed Description:
IXT-m200 is a monoclonal antibody that binds to methamphetamine in the blood. The main purpose of this study is to look at the effects of IXT-m200 on the pharmacokinetics of methamphetamine and on methamphetamine liking effects. Additionally, the study will determine IXT-m200 pharmacokinetics, safety and tolerability in subjects with methamphetamine use disorder. Qualified subjects will receive a single dose of IXT-m200 followed by up to 4 methamphetamine challenge doses.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01DA045366 | NIH | None | https://reporter.nih.gov/quic… | View |