IXT-m200 for Methamphetamine Addiction (OUTLAST Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: InterveXion Therapeutics, LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment for people trying to quit methamphetamine. It aims to see if the treatment can lower meth levels in the body and help with symptoms of meth addiction.

Eligibility Criteria

Adults seeking treatment for methamphetamine use disorder, with recent positive drug tests. Participants must be willing to follow study rules and attend all appointments, use approved birth control methods, have smartphone access for the study app, and meet DSM-5 criteria for Substance Use Disorder related to methamphetamine.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

I am not currently using recreational drugs, weight loss medications, or certain stimulants.

I am not allergic to monoclonal antibodies or any ingredients in IXT-m200.

My heart condition is not stable or well-controlled.

Participant Groups

The trial is testing IXT-m200's safety and effectiveness in reducing relapse rates compared to a placebo in individuals with Meth Use Disorder. It involves monthly IV doses and measures the reduction of stimulant-positive saliva samples following an initial relapse.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IXT-m200Experimental Treatment1 Intervention

Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g

Group II: PlaceboPlacebo Group1 Intervention

Saline