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Recruiting NCT06989853

Methamphetamine and Troriluzole

Early Phase I Interventional Methamphetamine Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Methamphetamine.
Who it may be relevant to
Registry conditions: Methamphetamine Use Disorder. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Placebo
    The effects of placebo will be determined.
  • Drug Methamphetamine
    Placebo and methamphetamine will be administered intravenously during experimental sessions.

Primary outcome measures

  • Reinforcing Effects of Methamphetamine [Time frame: 9 times over approximately 1 month inpatient admission]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Psychopharmacology of Addiction Laboratory — Lexington

Identifiers

NCT: NCT06989853 · 99084 · R01DA060632

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗