IXT-m200 for Methamphetamine Addiction

(OUTLAST Trial)

Overseen By Jayme Carr

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: InterveXion Therapeutics, LLC

Must not be taking: Opioids, Benzodiazepines, Designer drugs, others

Disqualifiers: Asthma, Cardiovascular disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called IXT-m200 for individuals struggling with methamphetamine addiction. The trial will determine if IXT-m200 can safely reduce methamphetamine use and improve symptoms compared to a placebo (inactive substance). Participants will receive monthly doses of either IXT-m200 or the placebo. The trial seeks individuals actively seeking treatment for methamphetamine addiction who have tested positive for methamphetamine during the screening phase. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you do not take certain drugs, including 'designer drugs,' weight loss medications, and some compounds like ephedrine and amphetamine. If you're taking these, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IXT-m200 has been tested for safety in people with methamphetamine addiction. In earlier studies, researchers administered this treatment to individuals who used methamphetamine and similar drugs. The results suggest that IXT-m200 is generally well-tolerated, as most participants did not experience adverse reactions.

These studies reported no major safety problems. Participants who received IXT-m200 did not experience severe side effects, indicating that the treatment might be safe for most people.

This trial is in Phase 2, indicating researchers have a reasonable level of confidence in its safety. Treatments reaching this phase have already demonstrated sufficient safety in earlier studies to warrant testing in larger groups. However, researchers will continue to closely monitor safety throughout the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for methamphetamine addiction?

Most treatments for methamphetamine addiction focus on behavioral therapies and medications aimed at managing withdrawal symptoms or cravings. But IXT-m200 works differently, targeting the drug itself with an anti-methamphetamine monoclonal antibody. This novel approach directly binds to methamphetamine in the bloodstream, potentially reducing its effects and helping to prevent relapse. Researchers are excited because this could provide a more direct and effective way to combat addiction, offering hope for those struggling with this condition.

What evidence suggests that IXT-m200 might be an effective treatment for methamphetamine addiction?

Research shows that IXT-m200, a special type of antibody, might help people with methamphetamine addiction. Earlier studies found that single doses of IXT-m200 are safe and can alter methamphetamine's effects in the body, potentially reducing the drug's impact. In this trial, some participants will receive IXT-m200 to further evaluate its effectiveness. Initial results also suggest that IXT-m200 could help prevent relapse in people with methamphetamine addiction. While more research is needed, these early findings offer hope for those struggling with meth addiction. ^{2 3 5 6 7}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

InterveXion Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/10686245

A First Multiple-Dose Efficacy Study of IXT-m200, an anti ...

Previous human studies of IXT-m200 have shown that single doses are safe and the antibody alters methamphetamine pharmacokinetics by reducing its volume of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05034874

NCT05034874 | Multiple-Dose Study to Evaluate the Safety ...

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine ...

3.

reporter.nih.gov

reporter.nih.gov/project-details/10154189

Meth-OD: A PHASE 2A STUDY OF IXT-M200 IN ...

This research should provide further evidence of the safety of IXT-m200 and early efficacy data supporting continued studies in treating methamphetamine ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04715230

Meth-OD: A Study of IXT-m200 in Patients With Toxicity ...

The hypothesis of this multisite Phase 2a study is that IXT-m200 will be well-tolerated in patients with acute mild to moderate METH toxicity.

5.

withpower.com

withpower.com/trial/phase-3-3-2022-71104

IXT-m200 for Methamphetamine Addiction (OUTLAST Trial)

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.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05027451

Safety, Tolerability, and Pharmacokinetics of IXT-m200

Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;; Have a history of stimulant use, including methamphetamine and amphetamine ...

7.

ctv.veeva.com

ctv.veeva.com/study/multiple-dose-study-to-evaluate-the-safety-and-efficacy-of-ixt-m200

Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT ...

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) ...