Troriluzole for Methamphetamine Addiction

(BED IN 46 Trial)

Overseen By William W Stoops, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Kentucky

Must not be taking: Chronic condition medications

Disqualifiers: Hypertension, BMI < 18 or > 30, others

Compensation: Varies

Number of Visits: 9

Duration: 1 month

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how troriluzole, a medication, affects the experience of using methamphetamine, a powerful stimulant. Participants will receive either a low or high dose of troriluzole or a placebo to determine if the treatment can alter the drug's effects. The trial targets individuals who have recently used methamphetamine and meet specific criteria for methamphetamine use disorder (MUD). This research could aid in developing new treatments for addiction. As an Early Phase 1 trial, it focuses on understanding how troriluzole works in people, offering participants a chance to contribute to groundbreaking addiction treatment development.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications prescribed for a chronic condition to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, troriluzole has shown potential in treating methamphetamine addiction. Troriluzole is similar to riluzole, a drug already approved by the FDA for another condition. This connection suggests that troriluzole might be safe for humans. Although detailed safety information for troriluzole in treating methamphetamine addiction is not yet available, the trial's early stage ensures careful monitoring of safety. So far, no major reports of serious side effects have emerged at the doses being tested. Participants might experience mild side effects, common in early trials, but overall, troriluzole appears well-tolerated based on its previous use and related research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about troriluzole for methamphetamine addiction because it offers a novel approach to treatment. Unlike current standard options, which often involve behavioral therapies and medications aimed at managing withdrawal or cravings, troriluzole works by modulating glutamate, a neurotransmitter involved in addiction pathways. This new mechanism of action could potentially reduce cravings and relapse rates more effectively. Additionally, with different dosing options (140 mg and 280 mg), troriluzole provides flexibility in treatment, potentially tailoring therapy to individual needs.

What evidence suggests that this trial's treatments could be effective for methamphetamine addiction?

Research has shown that troriluzole, a drug similar to riluzole, might help reduce methamphetamine use by affecting brain chemicals. In animal studies, troriluzole lowered methamphetamine use and reduced the urge to seek the drug. It also helped prevent the development of methamphetamine addiction. This trial will evaluate two different doses of troriluzole to determine its effectiveness in treating methamphetamine addiction. Although human studies have provided limited information, these early results offer hope for its potential in treating methamphetamine addiction. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-55 who use methamphetamine, are not seeking drug treatment, can speak/read English, have no allergies to troriluzole, and meet specific health criteria. Women must be on birth control and not pregnant or breastfeeding.

Inclusion Criteria

I am between 18 and 55 years old.

Must be able to speak/read English

Must not be seeking treatment for drug use at the time of the study

Exclusion Criteria

Must be seeking treatment for drug use

Must have no recent methamphetamine use as indicated by methamphetamine negative urine and no DSM-5 diagnosis of MUD

I am either younger than 18 or older than 55.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of troriluzole or placebo to evaluate its influence on methamphetamine effects

1 month

9 visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methamphetamine
• Troriluzole

Trial Overview The study tests the effects of a medication called troriluzole on individuals using methamphetamine. Participants will either receive this medication or a placebo to compare outcomes in a controlled environment.

How Is the Trial Designed?

Group I: Troriluzole Dose 2 Experimental Treatment 2 Interventions

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

Group II: Troriluzole Dose 1 Experimental Treatment 2 Interventions

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

Group III: Placebo Placebo Group 1 Intervention

Subjects will be treated daily with an oral placebo.

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06989853?term=METHAMPHETAMINE&rank=4

NCT06989853 | Methamphetamine and Troriluzole This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine . Supported by and included in the ...

2. reporter.nih.gov reporter.nih.gov/search/xGahxb1DMkaDIJlYA0Yf-Q/project-details/11073609

Advancing Troriluzole as a Treatment for Methamphetamine ... Troriluzole, a third-generation prodrug of riluzole, reduced methamphetamine intake and seeking behaviors in self-administration assays, inhibited development, ...

3. uky.trialstoday.org uky.trialstoday.org/trial/NCT06989853

Methamphetamine and Troriluzole Purpose. This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622004562

Troriluzole inhibits methamphetamine place preference in ... The profile of riluzole is favorable for normalizing glutamatergic dysregulation that perpetuates methamphetamine (METH) dependence, but ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06989853?intr=METHAMPEX&aggFilters=studyType:int&viewType=Table&rank=7

Study Details | Methamphetamine and Troriluzole Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study. Conditions. Methamphetamine Use Disorder. Methamphetamine Use ...

6. reporter.nih.gov reporter.nih.gov/project-details/11228856

Advancing Non-Abstinence Outcomes in the Treatment ... This trial seeks to determine whether reduced methamphetamine use improves outcomes like cardiovascular health, immune function, sleep quality and other ...

7. trialx.com trialx.com/clinical-trials/listings/300308/methamphetamine-and-troriluzole/

Methamphetamine and Troriluzole | Clinical Research Trial ... Overview. This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine.

8. withpower.com withpower.com/trial/troriluzole-for-methamphetamine-addiction-ad39e

Troriluzole for Methamphetamine Addiction (BED IN 46 Trial) The BED IN 46 medical study, being run by University of Kentucky, is evaluating whether Methamphetamine and Troriluzole will have tolerable side effects ...