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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 belowSelect...
I am 18 years old or older.
Select...
I am 18 years old or older.
OUTLAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 33 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 weeks
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 moreOther 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 moreSide effects data
From 2021 Phase 1 & 2 trial • 77 Patients • NCT0333686648%
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%
Tremor
1%
Cough
1%
Flushing
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
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
2,470 Previous Clinical Trials
2,619,611 Total Patients Enrolled
21 Trials studying Methamphetamine Abuse
1,302 Patients Enrolled for Methamphetamine Abuse
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
123 Previous Clinical Trials
21,574 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have recently had thoughts of hurting yourself or have attempted to hurt yourself in the past year.I completed most of the app's daily surveys and saliva tests within a month.I am 18 years old or older.I am not allergic to monoclonal antibodies or any ingredients in IXT-m200.I am 18 years old or older.You have been diagnosed with a substance use disorder specifically related to methamphetamine, according to the DSM-5 guidelines.You have had a serious allergic reaction to any medications in the past, which caused symptoms like rash, hives, or difficulty breathing.You currently have anorexia nervosa or bulimia disorder.I am not currently using recreational drugs, weight loss medications, or certain stimulants.You have been diagnosed with a substance use disorder specifically related to methamphetamine, based on the criteria outlined in the DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: IXT-m200
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Methamphetamine Abuse Patient Testimony for trial: Trial Name: NCT05034874 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently occurring for the trial participants?
"Affirmative. As presented on clinicaltrials.gov, this medical experiment is presently looking for participants and was first made available to the public on June 9th 2022. The most recent update occurred November 10th 2022, with a total of 120 patients sought across 10 different locations."
Answered by AI
Is there prior research with regards to the efficacy of IXT-m200?
"Currently, only one trial is underway for IXT-m200 and it's in the early stages. Nonetheless, there are 10 medical facilities conducting studies of this medication located primarily in DeSoto, Texas."
Answered by AI
To what extent is the population participating in this experiment increasing?
"InterveXion Therapeutics, LLC is in charge of this trial and must recruit a total of 120 qualified patients. The study will be managed out of Pillar Clinical Research located in Bentonville Arkansas as well as Woodlands International Research Group found in Little Rock Arizona."
Answered by AI
What are the safety implications of using IXT-m200?
"After a thorough assessment, IXT-m200 received a rating of 2 out of 3 due to its Phase 2 trial status. At this stage, there is evidence that it has passed safety tests but not yet any demonstrations of efficacy."
Answered by AI
What is the geographical spread of this research project?
"As part of this trial, 10 various sites are operating. These include the likes of Pillar Clinical Research in Bentonville, Woodlands International Research Group in Little Rock, and Alea Research in Phoenix to name but a few."
Answered by AI
Has a study like this ever been conducted before?
"Presently, a single experiment of IXT-m200 is running across 10 cities and one nation. This clinical trial, financed by InterveXion Therapeutics LLC., began in the year 2022 with 120 participants aiming for Phase 2 drug approval. Since then, 18330 studies were completed successfully."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
California
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Altea Research Institute
Artemis Institute for Clinical Research
HD Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
2
0
Why did patients apply to this trial?
to get off this drug. I want to beat this addiction. I want off this **** an it has ruined my life.
PatientReceived 1 prior treatment
I really wanna get off meth and I believe this trial will help me. I happened to see this study, and I would be interested in trying it. Since I do use.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Do you offer virtual? Where are studies held? Can this be done remotely with minimal travel?
PatientReceived no prior treatments
How often must I be in Houston? Weekly, monthly etc?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Alpine Research: < 24 hours
- Altea Research Institute: < 24 hours
- HD Research: < 48 hours
Average response time
- < 2 Days
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