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Taking people in United StatesEarly phase 1

Methamphetamine and Troriluzole

Key facts

Who runs it
William Stoops
Where
Lexington, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
40 people, planned
Started
25 Aug 2025
Expected to end
28 Feb 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo
  • Methamphetamine
Record updated
8 June 2026

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • able to speak/read English,
  • not seeking treatment for drug use at the time of the study,
  • female or male between the ages of 18 and 55 years,
  • recent methamphetamine use verified by methamphetamine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for MUD,
  • judged to be medically and psychiatrically healthy by study physicians other than the diagnosis for MUD (and OUD for the co-morbid MUD and OUD group, see below) at the time of screening,
  • ECG, read by a cardiologist, within normal limits,
  • females using an effective form of birth control and not pregnant or breastfeeding,
  • no known contraindications (e.g., hepatic disease [save for asymptomatic HCV status as cleared by study physician]) or allergies to troriluzole. Individuals in the MUD and OUD group must also report recent opioid use, verified by opioid positive urine, as well as fulfillment of DSM-5 diagnostic criteria for OUD with physiologic dependence (determined to not be physically dependent if a participant arrives with a urine sample for drug screening that is negative for a short-acting opioid and does not have a score of 5 or greater on the clinical opioid withdrawal scale [COWS])

Who cannot take part

  • seeking treatment for drug use,
  • blood pressure readings indicative of hypertension (i.e., blood pressure > 140/90 mmHg) on 2 consecutive screening visits,
  • taking any medications prescribed by a physician for a chronic condition,
  • history of serious physical disease or diagnosis of any disorder (e.g., current hepatic disease [save for asymptomatic HCV status; as noted above], histories of seizure, diabetes, asthma or CNS tumors) or current or past histories of psychiatric disorder, including current or recent suicidal ideation that would limit compliance in the study, other than MUD or tobacco use disorder (and OUD for the co-morbid MUD/OUD group only) that in the opinion of the study physicians would interfere with participation and
  • contraindications (e.g., hepatic disease) or allergies to troriluzole
  • any laboratory chemistry values (e.g., LFTs) > 3 times normal at screening or during admission,
  • unable to speak/read English,
  • under 18 years or over 55 years,
  • no recent methamphetamine use as indicated by methamphetamine negative urine and no DSM-5 diagnosis of MUD,
  • judged to be medically and psychiatrically unhealthy by study physicians at the time of screening,
  • ECG, read by a cardiologist, outside normal limits,
  • females not using an effective form of birth control or pregnant or breastfeeding,
  • BMI < 18 or > 30; weight < 50 kg,

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Where in United States

  • Psychopharmacology of Addiction LaboratoryLexington, United StatesContact: William W Stoops, PhDTaking people

About the trial

What the trial wants to find out

This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine. Supported by and included in the Helping to End Addiction Long-term® (HEAL) Initiative.

The 3 groups in the trial

  • PlaceboPlacebo, for comparison

    Subjects will be treated daily with an oral placebo.

  • Troriluzole Dose 1Treatment being tested

    Subjects will be treated daily with oral troriluzole (140 mg).

    Treatment: Placebo and Methamphetamine

  • Troriluzole Dose 2Treatment being tested

    Subjects will be treated daily with oral troriluzole (280 mg).

    Treatment: Placebo and Methamphetamine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study
Fit questions
Built from NCT06989853, who can take part
Record updated
8 June 2026