Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06989853

Methamphetamine and Troriluzole

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

Location status: Recruiting

Location contact

William W Stoops, PhD

CONTACT

[email protected]

859-257-5388

William W Stoops, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]).

Exclusion criteria

  • unable to speak/read English,
  • seeking treatment for drug use,
  • 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,
  • blood pressure readings indicative of hypertension (i.e., blood pressure > 140/90 mmHg) on 2 consecutive screening visits,
  • BMI < 18 or > 30; weight < 50 kg,
  • taking any medications prescribed by a physician for a chronic condition,
  • any laboratory chemistry values (e.g., LFTs) > 3 times normal at screening or during admission,
  • 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.

Treatment and study plan

Placebo

Drug

The effects of placebo will be determined.

Methamphetamine

Drug

Placebo and methamphetamine will be administered intravenously during experimental sessions.

Primary outcomes

  1. Reinforcing Effects of Methamphetamine

    Time frame: 9 times over approximately 1 month inpatient admission

    Number of Times Subjects Hypothetically Choose Methamphetamine Over Money between $0 and $140

Study contacts

Contact information is provided by the study sponsor or research team.

William W Stoops, PhD

CONTACT

[email protected]

859-257-5388

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: BED IN 46

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 25, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.