Methamphetamine Use DisorderEarly Phase 1BED IN 46NCT06989853
Methamphetamine and Troriluzole
A Early Phase 1 study testing Methamphetamine in people with Methamphetamine Use Disorder, run by William Stoops at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Methamphetamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 28 Feb 2029
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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]).
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, 40507
William W Stoops, PhD, 859-257-5388, william.stoops@uky.edu
William W Stoops, PhD
About this study
Official title: Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study
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
- Being tested
- Placebo, Methamphetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The effects of placebo will be determined.
MethamphetamineDrug
Placebo and methamphetamine will be administered intravenously during experimental sessions.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be treated daily with an oral placebo. Receives: Drug: Placebo |
| Troriluzole Dose 1 | Experimental | Subjects will be treated daily with oral troriluzole (140 mg). Receives: Drug: Placebo; Drug: Methamphetamine |
| Troriluzole Dose 2 | Experimental | Subjects will be treated daily with oral troriluzole (280 mg). Receives: Drug: Placebo; Drug: Methamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects of Methamphetamine
Number of Times Subjects Hypothetically Choose Methamphetamine Over Money between $0 and $140
Measured: 9 times over approximately 1 month inpatient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start25 Aug 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989853
- Sponsor's protocol ID
- 99084
- Other IDs
- R01DA060632
- Acronym
- BED IN 46
- Status last verified
- Jun 2026
- First submitted
- 9 May 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data from this project will be preserved and shared through an NIH-funded repository. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes.