Methamphetamine and Troriluzole

NCT06989853 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 99084R01DA060632
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (1)

• Reinforcing Effects of Methamphetamine

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

  9 times over approximately 1 month inpatient admission

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will be treated daily with an oral placebo.

Drug: Placebo

Troriluzole Dose 1

EXPERIMENTAL

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

Drug: Placebo; Drug: Methamphetamine

Troriluzole Dose 2

EXPERIMENTAL

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

Drug: Placebo; Drug: Methamphetamine

Interventions

Placebo DRUG

The effects of placebo will be determined.

Placebo; Troriluzole Dose 1; Troriluzole Dose 2

Methamphetamine DRUG

Placebo and methamphetamine will be administered intravenously during experimental sessions.

Troriluzole Dose 1; Troriluzole Dose 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[COWS\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

RECRUITING

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

William W Stoops, PhD

CONTACT

859-257-5388; william.stoops@uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 02/28/2029 (anticipated); available in perpetuity
• Access Criteria: investigators working under an institution with a Federal Wide Assurance (FWA)

Locations

US (1)