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Идёт набор NCT05064319

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

Фаза II С лечением Bipolar Disorder Cannabis Use Schizoaffective Disorder, Bipolar Type Bipolar I Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gabapentin, Placebo.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type, Bipolar I Disorder. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study

Обзор

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Вмешательства

  • Препарат Gabapentin
    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.
  • Препарат Placebo
    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days.

Первичные конечные точки

  • Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy [Срок оценки: Baseline to end of treatment, approximately 17 days]

Критерии участия

Критерии включения

  • Ages 18-65 years
  • Meet DSM-5 criteria for moderate or severe cannabis use disorder (CUD; within the past 3 months), provide a positive urine cannabinoid screen at baseline, and identify cannabis as the primary substance of abuse
  • Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
  • Able to provide informed consent and read, understand, and accurately complete assessment instruments
  • Willing to commit to medication treatment and follow-up assessments
  • Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)

Критерии исключения

  • A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
  • Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
  • Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
  • Any history of brain injury with loss of consciousness greater than 5 minutes
  • Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
  • Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
  • Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
  • Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
  • Concomitant use of medications that could interfere with glutamatergic/GABAergic transmission (e.g., benzodiazepines, ceftriaxone, riluzole, memantine, ketamine, topiramate, vigabatrin), due to potential confounding effects
  • Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
  • Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
  • Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
  • Current suicidal or homicidal risk
  • Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
  • Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
  • Significant claustrophobia and/or past negative experiences with MRI
  • Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University Of South Carolina — Charleston

Идентификаторы

NCT: NCT05064319 · 00112593 · R01DA054275

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗