Troriluzole and methamphetamine response

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

This study will see if taking troriluzole changes how methamphetamine affects adults with methamphetamine use disorder.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT06989853 on ClinicalTrials.gov

What this trial studies

This is an early-phase human laboratory study where people with methamphetamine use disorder will receive either troriluzole or placebo and then controlled doses of methamphetamine in a clinic setting to measure drug effects. Participants must be 18–55, medically and psychiatrically stable, not seeking treatment, and have recent methamphetamine use confirmed by urine test. The protocol includes cardiac screening and contraception requirements for women of childbearing potential, and excludes those with contraindications to troriluzole. The work is supported by the HEAL Initiative and NIDA and is conducted at the Psychopharmacology of Addiction Laboratory in Lexington, Kentucky.

Who should consider this trial

Good fit: Adults aged 18–55 with current methamphetamine use disorder who have recent methamphetamine-positive urine, are medically and psychiatrically stable, not seeking treatment, and (if female) agree to use effective birth control.

Not a fit: People seeking treatment for methamphetamine use, pregnant or breastfeeding women, those with significant medical or psychiatric conditions, or with known contraindications or allergies to troriluzole are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this could show whether troriluzole reduces the rewarding or subjective effects of methamphetamine and inform development of medications for methamphetamine use disorder.

How similar studies have performed: Glutamate-modulating medications have shown mixed results in substance use disorders, and troriluzole's effects on stimulant response in humans remain largely untested.

Eligibility criteria

Inclusion Criteria:

1. able to speak/read English,
2. not seeking treatment for drug use at the time of the study,
3. female or male between the ages of 18 and 55 years,
4. recent methamphetamine use verified by methamphetamine positive urine, as well as fulfillment of DSM-5 diagnostic criteria for MUD,
5. 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,
6. ECG, read by a cardiologist, within normal limits,
7. females using an effective form of birth control and not pregnant or breastfeeding,
8. 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:

1. unable to speak/read English,
2. seeking treatment for drug use,
3. under 18 years or over 55 years,
4. no recent methamphetamine use as indicated by methamphetamine negative urine and no DSM-5 diagnosis of MUD,
5. judged to be medically and psychiatrically unhealthy by study physicians at the time of screening,
6. ECG, read by a cardiologist, outside normal limits,
7. females not using an effective form of birth control or pregnant or breastfeeding,
8. blood pressure readings indicative of hypertension (i.e., blood pressure \> 140/90 mmHg) on 2 consecutive screening visits,
9. BMI \< 18 or \> 30; weight \< 50 kg,
10. taking any medications prescribed by a physician for a chronic condition,
11. any laboratory chemistry values (e.g., LFTs) \> 3 times normal at screening or during admission,
12. 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
13. contraindications (e.g., hepatic disease) or allergies to troriluzole.

Where this trial is running

Lexington, Kentucky

• Psychopharmacology of Addiction Laboratory — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Study coordinator: William W Stoops, PhD

Conditions Methamphetamine Use Disorder