Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (Meth-OD)

This is an interventional treatment trial for Methamphetamine Intoxication (Disorder) Read More

Inclusion Criteria:

1. Be aged 18 to 45 years, inclusive;
2. Present to the ED with METH toxicity as defined in protocol;
3. Have a PANSS-EC score of 14-28, inclusive;
4. Have or agrees to have an intravenous (IV) line placed;
5. Give a history of METH use in the past 24 hours, with participant or observer attribution of symptoms to METH, or have a positive METH drug screen;
6. Be accompanied or readily represented by a legally authorized representative (surrogate) who can consent to participation on behalf of the participant; and
7. Assent to participation in the study.

Exclusion Criteria:

1. Present with concomitant opioid overdose requiring ventilatory support;
2. Be self-reported to be pregnant or lactating;

3. Be considered to have significant concomitant medical illness or trauma, or symptoms of severe METH toxicity including

   1. sepsis or febrile illness;
   2. myocardial infarction, cardiac decompensation or arrhythmias including tachycardia that is not sinus; severe hypertension (>180/110 mmHg); inadequately treated hypertension on chronic medication; history of vasculitis
   3. coma, stroke or severe head injury; new or ongoing seizure activity
   4. acute pulmonary decompensation or severe chronic obstructive pulmonary disease;
   5. any hepatic impairment and/or acute hepatitis or renal impairment due to concomitant medical illness; or
   6. current, or history of, neuroleptic malignant syndrome
4. Be considered to be at imminent risk of suicide or have disqualifying answers to the following two questions. Disqualifying answers would be 1b2 or 2b. 1. In the past 30 days, have you considered killing yourself? a) No; b) Yes - if Yes, how often? b1) Not often (twice or less), b2) Somewhat often (more than twice). 2. In the past year, have you attempted to kill yourself? a) No; b) Yes;
5. Be considered to be at imminent risk of injury or danger to self, others or property;
6. Have a history of severe allergy (rash, hives, breathing difficulty, etc.), known hypersensitivity or infusion reaction to any antibody medications, lorazepam or haloperidol; or
7. Be judged by the treating ED physician, investigator, or Sponsor (or designee) to be inappropriate for the study, including people whom the investigator determines cannot reasonably be consulted for assent to participation.