Actively Recruiting

Early Phase 1
Age: 18Years - 55Years
All Genders
ID06989853

Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study

Led by William Stoops · Updated on 2026-06-08

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

W

William Stoops

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of troriluzole, an investigational drug, on the influence of methamphetamine in people with methamphetamine use disorder. This human laboratory study is part of the Helping to End Addiction Long-term® (HEAL) Initiative, aiming to better understand how troriluzole might affect the reinforcing properties of methamphetamine in this population. Participants will be randomly assigned to one of three groups: daily oral placebo, daily oral troriluzole 140 mg, or daily oral troriluzole 280 mg. During experimental sessions, intravenous methamphetamine or placebo will be administered to assess the drug's effects while participants are admitted as inpatients for about one month. Participants will stay in the inpatient setting for approximately one month, during which they will undergo nine assessments of methamphetamine's reinforcing effects. Researchers will monitor health through medical and psychiatric evaluations, ECG readings, urine drug tests, and careful observation for any side effects. The study aims to gather detailed information about how troriluzole impacts methamphetamine use and related behaviors.

CONDITIONS

Brief Title

Methamphetamine and Troriluzole

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to speak and read English
  • Not seeking treatment for drug use at the time of the study
  • Female or male between 18 and 55 years old
  • Recent methamphetamine use verified by positive urine test and DSM-5 diagnosis of methamphetamine use disorder
  • Medically and psychiatrically healthy aside from methamphetamine use disorder (and opioid use disorder if co-morbid), as judged by study physicians
  • ECG within normal limits as read by a cardiologist
  • Females using effective birth control and not pregnant or breastfeeding
  • No known contraindications or allergies to troriluzole
  • For co-morbid methamphetamine and opioid use disorder group: recent opioid use verified by positive urine test and DSM-5 diagnosis of opioid use disorder with physiological dependence
Not Eligible

You will not qualify if you...

  • Unable to speak or read English
  • Seeking treatment for drug use
  • Under 18 or over 55 years old
  • No recent methamphetamine use (negative urine test) and no DSM-5 diagnosis of methamphetamine use disorder
  • Medically or psychiatrically unhealthy as judged by study physicians
  • ECG outside normal limits as read by a cardiologist
  • Females not using effective birth control or who are pregnant or breastfeeding
  • Blood pressure higher than 140/90 mmHg on two consecutive screening visits
  • Body mass index less than 18 or greater than 30; weight under 50 kg
  • Taking any medications prescribed for a chronic condition
  • Laboratory values more than three times normal at screening or during admission
  • History of serious physical disease or diagnosis including seizure, diabetes, asthma, CNS tumors, or current/recent psychiatric disorders (other than methamphetamine use disorder or tobacco use disorder, and opioid use disorder if co-morbid) that would limit study compliance
  • Contraindications or allergies to troriluzole such as hepatic disease (except asymptomatic HCV status cleared by physician)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits during screening

Treatment

Duration - Approximately 1 month inpatient admission

Participants receive daily oral doses of placebo or troriluzole (140 mg or 280 mg) while undergoing experimental sessions with intravenous placebo and methamphetamine to study their effects.

9 experimental sessions during inpatient admission

Trial Site Locations

Total: 1 location

1

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, United States, 40507

Actively Recruiting

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Research Team

W

William W Stoops, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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