Methamphetamine and Troriluzole

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Placebo
  The effects of placebo will be determined.
• Препарат Methamphetamine
  Placebo and methamphetamine will be administered intravenously during experimental sessions.

Первичные конечные точки

• Reinforcing Effects of Methamphetamine [Срок оценки: 9 times over approximately 1 month inpatient admission]

Критерии участия

Критерии включения

• 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 \[COWS\]).

Критерии исключения

• 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,
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Psychopharmacology of Addiction Laboratory — Lexington

Идентификаторы

NCT: NCT06989853 · 99084 · R01DA060632

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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