Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
EARLY_PHASE1
40 participants
INTERVENTIONAL
2025-08-25
2029-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Subjects will be treated daily with an oral placebo.
Placebo
The effects of placebo will be determined.
Troriluzole Dose 1
Subjects will be treated daily with oral troriluzole (140 mg).
Placebo
The effects of placebo will be determined.
Methamphetamine
Placebo and methamphetamine will be administered intravenously during experimental sessions.
Troriluzole Dose 2
Subjects will be treated daily with oral troriluzole (280 mg).
Placebo
The effects of placebo will be determined.
Methamphetamine
Placebo and methamphetamine will be administered intravenously during experimental sessions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
The effects of placebo will be determined.
Methamphetamine
Placebo and methamphetamine will be administered intravenously during experimental sessions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
William Stoops
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
William Stoops
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
William W Stoops, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
99084
Identifier Type: -
Identifier Source: org_study_id