Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Официальное название

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study

Обзор

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Вмешательства

• Препарат SUVO
  Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
• Препарат TAU
  Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Первичные конечные точки

• Change in total sleep duration as assessed by the actigraphy watch [Срок оценки: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11]
• Change in wake after sleep onset measured via actigraphy watch [Срок оценки: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11]
• Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI) [Срок оценки: Day 5 and Day 12]
• Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) [Срок оценки: Day 5 and Day 12]
• Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) [Срок оценки: Day 5 and Day 12]
• Change in self-reported stress as assessed by the Visual Analog Scale (VAS) [Срок оценки: Day 5 and Day 12]
• Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS) [Срок оценки: Day 5 and Day 12]
• Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ) [Срок оценки: Day 5 and Day 12]

Вторичные конечные точки (10)

• Change in resting state alpha power as assessed by EEG [Срок оценки: Day 5 and Day 12]
• Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task [Срок оценки: Day 5 and Day 12]
• Change in stress as indicated by the change in heart rate during the cold-pressor task [Срок оценки: Day 5 and Day 12]
• Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes [Срок оценки: Day 5 and Day 12]
• Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes [Срок оценки: Day 5 and Day 12]
• Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task [Срок оценки: Day 5 and Day 12]
• Change in intensity of demand as assessed by the Drug Purchasing Task [Срок оценки: Day 5 and Day 12]
• Length of stay (LOS) [Срок оценки: at time of discharge (up to 30 days form baseline)]
• Percentage of participants who complete the 30 day treatment [Срок оценки: at time of discharge (up to 30 days form baseline)]
• Change in side effects as assessed by the side effects questionnaire [Срок оценки: Day 5 , Day 12]

Критерии участия

Критерии включения

• Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
• Be fluent in English and able to understand the consent form

Критерии исключения

• Have an opioid use disorder of any severity
• Have a greater than moderate substance use disorder on any other substance
• Undergoing medication-assisted treatment for withdrawal of any substance
• Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
• Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
• Are pregnant or breast feeding
• BMI > 30 (women only)
• Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
• Have history of seizure disorder
• Have a head injury with loss of consciousness in the last 5 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06444256 · HSC-MS-24-0330

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗