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

Awards & highlights

Summary

This trial will test a new drug, IXT-m200, to see if it is safe and effective in treating people with methamphetamine use disorder. The hypothesis is that IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

48%

Euphoric mood

26%

Hypervigilance

19%

Feeling hot

18%

Palpitations

13%

Injection site pain

12%

Hyperhidrosis

12%

Headache

10%

Dry mouth

Dizziness

Tachycardia

Energy increased

Bruxism

Paraesthesia

Nausea

Fatigue

Feeling abnormal

Restlessness

Catheter site pain

Abdominal discomfort

Hot flush

Logorrhoea

Decreased appetite

Anxiety

Disgeusia

Vomiting

Disturbance in sexual arousal

Flushing

Cough

Tremor

Skin laceration

Dysarthria

Heart rate increased

Discomfort

Chest discomfort

Restless legs syndrome

Oropharyngeal pain

Dermatitis contact

Hypertension

Ear pain

Thirst

Electrocardiogram ST segment depression

Electrocardiogram ST-T change

Hepatic enzyme increased

Hyperaesthesia

Migraine with aura

Eye irritation

Visual impairment

Abdominal pain

Insomnia

Change in sustained attention

Sputum increased

100%

80%

60%

40%

20%

Study treatment Arm

All Subjects: Day 1-3

Placebo: Day 4-126

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

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

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.