NCT03336866

Study of Antibody for Methamphetamine Outpatient Therapy

STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: InterveXion Therapeutics, LLC · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Methamphetamine-dependence
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	Placebo	Normal saline
DRUG	IXT-m200	IXT-m200 is an anti-methamphetamine monoclonal antibody

Timeline

• Start date: 2018-05-03
• Primary completion: 2020-11-23
• Completion: 2021-03-09
• First posted: 2017-11-08
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study