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Monoclonal Antibodies

IXT-m200 for Methamphetamine Intoxication (Meth-OD 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 aged 18 to 45 years, inclusive;
Have a PANSS-EC score of 14-28, inclusive;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Awards & highlights

Meth-OD Trial Summary

This trial is testing a new antibody to see if it's effective and safe in treating people with mild to moderate methamphetamine toxicity.

Eligible Conditions
  • Methamphetamine Intoxication

Meth-OD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have or agree to have an IV line placed.

Meth-OD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment until discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment until discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
Number of Patients With Treatment-related AEs as Measured by Physical Examinations
+1 more
Secondary outcome measures
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
+2 more
Other outcome measures
Length of Patient Stay in the ED

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%
Cough
1%
Flushing
1%
Skin laceration
1%
Tremor
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

Meth-OD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IXT-m200Experimental Treatment1 Intervention
IXT-m200 is a high-affinity chimeric anti-METH monoclonal antibody that is well-tolerated in healthy volunteers and in non-intoxicated people with METH use disorder. The total dose will be given over 10 min for the 0.5-g dose and over 20 min for the 1-, 1.5-, and 2-g doses.
Group II: Treatment as Usual (TAU)Active Control2 Interventions
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting. Haloperidol is commonly used to treat agitation due to psychosis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IXT-m200
2021
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,594,046 Total Patients Enrolled
InterveXion Therapeutics, LLCLead Sponsor
4 Previous Clinical Trials
248 Total Patients Enrolled
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
122 Previous Clinical Trials
21,549 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does IXT-m200 pose a threat to human health?

"Taking all information into consideration, our team at Power assigned IXT-m200 a safety score of 2 as it is only in Phase 2 clinical trials. This suggests some evidence of its safety but no proof yet of efficacy."

Answered by AI

What other research has been undertaken featuring IXT-m200?

"Initially studied in 2012 at Chaim Sheba Medical Center, IXT-m200 has since been subject to 143 completed investigations. Currently, 15 trials are running around the world; with a concentration of them being located in Spokane, Washington."

Answered by AI

How many individuals are being included in this research program?

"This clinical trial necessitates 40 participants, meeting the established criteria, to participate. Those interested can enrol at Sacred Heart Medical Center in Spokane or Providence Regional Medical Center Everett in New mexico."

Answered by AI

Are there any restrictions on who may participate in this clinical experiment?

"This clinical experiment is accepting individuals aged between 18 and 45 who have experienced a drug overdose. Currently, 40 participants are required to complete the trial."

Answered by AI

Is this research project still accepting participants?

"This clinical trial, which was inaugurated on June 30th 2021, is still actively seeking participants. The study's specifications were last amended on December 7th 2022 according to data available from clinicialtrials.gov."

Answered by AI

For what applications is IXT-m200 typically employed?

"IXT-m200 is an investigational drug that has potential in treating schizophrenia, phencyclidine intoxication, and terminal illness palliative care."

Answered by AI

Is the patient pool for this trial restricted to those under 40 years of age?

"As stated in the prerequisites for participation, individuals must be between 18 and 45 years old to qualify."

Answered by AI

What is the main goal of this investigation?

"This 28-day trial intends to measure the amount of treatment related adverse events through laboratory tests. Secondary targets include tracking changes in blood pressure and heart rate over time, as well as recording patients who need additional medication for psychiatric or cardiovascular reactions to methamphetamine toxicity."

Answered by AI

Are there numerous medical facilities in North America that are currently conducting the clinical investigation?

"At the current moment, 4 medical centres are participating in this trial. These locations can be found in Spokane Washington, Everett Washington, Albuquerque New mexico and at additional facilities. If you plan to join this study it is crucial that you select a site nearest your abode to reduce commuting requirements."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
Arkansas
Washington
How old are they?
18 - 65
What site did they apply to?
Providence Regional Medical Center Everett
University of Arkansas for Medical Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I want to quit this habit and change my life be here for my 4 kids and see them grow up.
PatientReceived 2+ prior treatments
I have recently been diagnosed with pretty severe heart failure in the right side of my heart. I am 35 years old.?Walking at a normal pace raises my heart rate to 150 at times. It has become a struggle to do things like climb stairs, change my clothes and put on my shoes. I take a diuretic now, but unless I can stop doing meth I won’t get better. I really would like my quality of life to improve. A friend recommended this to me.
PatientReceived 1 prior treatment
~5 spots leftby Mar 2025