What side effects are associated with this type of intervention?

Treatments for methamphetamine abuse, such as IXT-m200, aim to reduce methamphetamine effects or cravings. Common side effects of these treatments can include gastrointestinal issues (nausea, diarrhea), neurological symptoms (headache, dizziness), and psychological effects (anxiety, confusion). In clinical trials, higher dropout rates are often observed due to adverse effects, which can also include impaired concentration and paresthesias. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of methamphetamine abuse. However, various treatments are being studied to address this issue. For instance, the trial IXT-m200 is investigating the efficacy of a monthly intravenous dose to reduce methamphetamine effects and cravings. Other treatments under research include medications like bupropion and naltrexone, which have shown some promise in reducing cravings and usage in clinical trials.

What other types of research exist?

Promising alternatives to IXT-m200 for methamphetamine abuse treatment include: 1) Bupropion and naltrexone combination therapy, which has shown efficacy in reducing methamphetamine use in clinical trials. 2) Transcranial magnetic stimulation (TMS), which has demonstrated potential in reducing cravings and improving mood in substance use disorders. 3) Cognitive-behavioral therapy (CBT) and contingency management, which are effective non-pharmacological approaches for reducing methamphetamine use and preventing relapse.

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IXT-m200 for Methamphetamine Addiction (OUTLAST Trial)

Phase 2

Waitlist Available

Research Sponsored by InterveXion Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years of age at the time of study consent

Must not have

Be currently taking certain other drugs and medications, including: 'designer drugs' (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine)

Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other monoclonal antibodies, any inactive ingredient of IXT-m200, or any other products required for the study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 33 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include reactions similar to other monoclonal antibodies such as infusion-related reactions, allergic responses or sensitivities due to ingredients in IXT-m200.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My heart condition is not stable or well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~33 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of 20 weeks abstinent from stimulants following a 4-week grace period

Secondary study objectives

Change from screening in participant-rated quality of life as measured by the Treatment Effectiveness Assessment

Complete abstinence during last month of study drug treatment

Difference between groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33

+8 more

Other study objectives

Number of sequential weeks of abstinence from the end of treatment

Point prevalence abstinence (last 7 days)

Proportion of responders in early remission at Week 33 as measured by DSM-5 criteria

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 77 Patients • NCT03336866

72%

Euphoric mood

44%

Palpitations

33%

Injection site pain

33%

Hypervigilance

33%

Headache

28%

Nausea

28%

Tachycardia

17%

Catheter site pain

17%

Feeling hot

17%

Hyperhidrosis

17%

Dry mouth

11%

Influenza like illness

11%

Vomiting

11%

Abdominal discomfort

11%

Tremor

Constipation

Cellulitis

Vibratory sense increased

Feeling abnormal

Skin laceration

Haematuria

Dizziness

Vision blurred

Dry skin

Bruxism

Mood altered

Contusion

Blood creatine phosphokinase increased

Glycosylated haemoglobin increased

Eye contusion

Ear pruritis

Toothache

Abdominal distension

Catheter site inflammation

Injection site erythema

Seasonal allergy

Cough

Nasal disorder

Pain

Catheter site nodule

Gastroenteritis

Diarrhoea

Musculoskeletal pain

Sinus headache

Somnolence

Restlessness

Nasal dryness

Rhinorrhoea

Sinus congestion

Tachypnoea

Acne

Dermatitis contact

Rash macular

Skin lesion

Drug abuser

Phlebitis

Visual impairment

Feeling of relaxation

Neck pain

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo: Day 4-126

IXT-m200, 20 mg/kg: Day 4-126

IXT-m200, 6 mg/kg: Day 4-126

All Subjects: Day 1-3

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IXT-m200

2021

Completed Phase 2

~90

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for methamphetamine abuse, such as IXT-m200, aim to reduce the effects or cravings associated with methamphetamine use. These treatments often work by targeting the brain's reward system, particularly the dopamine pathways, which are heavily impacted by methamphetamine. For instance, medications like varenicline act as selective nicotinic acetylcholine receptor agonists, which can modulate dopamine release and reduce cravings. Other treatments may include cognitive-behavioral therapy (CBT) to help patients modify behaviors and thoughts related to substance use. These mechanisms are crucial for patients as they help to mitigate the intense cravings and withdrawal symptoms, making it easier to maintain abstinence and improve overall treatment outcomes.

Music therapy for people with substance use disorders.Effects of repeated hair washing and a single hair dyeing on concentrations of methamphetamine and amphetamine in human hairs.