IXT-m200 for Methamphetamine Addiction

(OUTLAST Trial)

Recruiting at -1 trial locations

Overseen By Jayme Carr

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: InterveXion Therapeutics, LLC

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

61 Participants Needed

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.

Research Team

Chief Medical Officer

Principal Investigator

InterveXion Therapeutics

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

Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period

Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent

Agree to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

You have had asthma caused by allergies or the environment in the last three years.

My heart condition is not stable or well-controlled.

Be mandated by the court to obtain treatment for methamphetamine-dependence where such mandate required the results of methamphetamine testing to be reported to the court

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly intravenous doses of IXT-m200 or placebo

20 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Treatment Details

Interventions

• IXT-m200
• Placebo

Trial Overview 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.

Participant Groups

Group I: IXT-m200 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Saline

Who Is Running the Clinical Trial?

InterveXion Therapeutics, LLC

Lead Sponsor

Trials

5

Recruited

210+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+