RECRUITING

Methamphetamine and Troriluzole

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-15

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06989853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 \[COWS\]).	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.

Inclusion Criteria

Exclusion 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 \[COWS\]).

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.

Contacts and Locations

Study Contact

William W Stoops, PhD

CONTACT

859-257-5388

william.stoops@uky.edu

Study Locations (Sites)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507

United States

Collaborators and Investigators

Sponsor: University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-08-15

Study Completion Date2029-02-28

Terms related to this study

Additional Relevant MeSH Terms

Methamphetamine Use Disorder