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

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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 have ECG within normal limits as read by a cardiologist

Must be able to speak/read English

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

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

Treatment Details

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.

Participant Groups

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+