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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
Be at least 18 years of age at the time of study consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 weeks
Awards & highlights

OUTLAST Trial 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.

OUTLAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.

OUTLAST Trial Timeline

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
9%
Dizziness
9%
Tachycardia
8%
Energy increased
8%
Bruxism
6%
Paraesthesia
5%
Nausea
5%
Fatigue
5%
Feeling abnormal
5%
Restlessness
4%
Catheter site pain
4%
Abdominal discomfort
4%
Hot flush
4%
Logorrhoea
3%
Decreased appetite
3%
Anxiety
3%
Disgeusia
3%
Vomiting
3%
Disturbance in sexual arousal
1%
Flushing
1%
Cough
1%
Tremor
1%
Skin laceration
1%
Dysarthria
1%
Heart rate increased
1%
Discomfort
1%
Chest discomfort
1%
Restless legs syndrome
1%
Oropharyngeal pain
1%
Dermatitis contact
1%
Hypertension
1%
Ear pain
1%
Thirst
1%
Electrocardiogram ST segment depression
1%
Electrocardiogram ST-T change
1%
Hepatic enzyme increased
1%
Hyperaesthesia
1%
Migraine with aura
1%
Eye irritation
1%
Visual impairment
1%
Abdominal pain
1%
Insomnia
1%
Change in sustained attention
1%
Sputum increased
100%
80%
60%
40%
20%
0%
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

OUTLAST 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

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.

Who is running the clinical trial?

InterveXion Therapeutics, LLCLead Sponsor
4 Previous Clinical Trials
148 Total Patients Enrolled
2 Trials studying Methamphetamine Abuse
119 Patients Enrolled for Methamphetamine Abuse
National Institute on Drug Abuse (NIDA)NIH
2,497 Previous Clinical Trials
2,623,869 Total Patients Enrolled
23 Trials studying Methamphetamine Abuse
1,477 Patients Enrolled for Methamphetamine Abuse
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
124 Previous Clinical Trials
21,753 Total Patients Enrolled

Media Library

IXT-m200 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05034874 — Phase 2
Methamphetamine Abuse Research Study Groups: IXT-m200, Placebo
Methamphetamine Abuse Clinical Trial 2023: IXT-m200 Highlights & Side Effects. Trial Name: NCT05034874 — Phase 2
IXT-m200 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034874 — Phase 2
Methamphetamine Abuse Patient Testimony for trial: Trial Name: NCT05034874 — Phase 2
~20 spots leftby Jun 2025