Ketamine for Opioid Use Disorder

Официальное название

Ketamine for the Treatment of Opioid Use Disorder

Обзор

The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are: * Does ketamine reduce craving for opioids in patients with opioid use disorder? * Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality? * Do patients who take the low dose ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the very low dose? Researchers will compare two low doses of ketamine to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. Participants will: * Be given a low dose or a very low dose of ketamine 4 times over a period of 2 weeks * Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake

Вмешательства

• Препарат Treatment with Ketamine
  Participants will receive four doses of ketamine spaced 1-6 days apart of 0.75 mg/kg intramuscular ketamine (n=25) for two weeks (first ketamine session must occur no later than 28 days post-intake). Individuals will be monitored for two hours post-dose by a clinician.
• Препарат Treatment with Very Low Dose Ketamine
  Participants will receive four doses of very low dose ketamine (0.1mg.kg) (n=25) spaced 1-6 days apart for two weeks (first ketamine session must occur no later than 28 days post-intake). Individuals will be monitored for two hours post-dose by a clinician.

Первичные конечные точки

• Tonic craving (FORCAST) total scores [Срок оценки: Collected at baseline, weekly, 30-, 60-, and 90 days post-intake]

Вторичные конечные точки (9)

• Severity of depression symptoms [Срок оценки: Completed at baseline, weekly, 30-, 60-, and 90 days post-intake]
• Cue-induced craving scores [Срок оценки: Collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake]
• Chronic pain ratings [Срок оценки: Collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake]
• Number of methadone doses received at 90 days post-intake [Срок оценки: Collected through 90 days post-intake]
• Sleep quality ratings [Срок оценки: PSQI collected at Baseline and 30-, 60-, and 90 days post-intake]
• Insomnia Symptoms [Срок оценки: ISI collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake]
• Sleep quality ratings on a Visual Analogue Scale (VAS) [Срок оценки: SQS collected via daily optional EMAs through 90 days post-intake]
• Scores on a holistic measure of recovery [Срок оценки: Collected at baseline and at 30-, 60-, and 90 days post-intake]
• Frequency of negative urine drug screens through 90 days post-intake [Срок оценки: collected through 90 days post-intake]

Критерии участия

Критерии включения

• Age 18 to 65 years old
• Recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week
• Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder
• Acceptance into methadone treatment for opioid use disorder within the past 21 days at the time of screening
• Adherence to lifestyle requirements for participation

Критерии исключения

• Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake
• Pregnant and/or breastfeeding
• \*\*Stage 2 Hypertension, defined by a systolic blood pressure (SBP) > 140mmHg or a diastolic blood pressure (DBP) > 90 mmHg
• Abnormal oxygen saturation or abnormal heart rate (i.e. O2 saturation <95%, or HR <60 or >100bpm)
• Clinically significant abnormal findings for which study participation is deemed unsafe
• Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder)
• \*\*ALT/AST > 3 x Upper Limit of Normal (ULN), ALP 2 x ULN, or total bilirubin > 1.5 x ULN. Source: Labs
• History of hypersensitivity to ketamine
• Suicidal ideation with a plan or intent or suicidal behaviors as reflected in Columbia-Suicide Severity Rating Scale (C-SSRS)
• Recent homicidal ideation or violent behaviors
• Concomitant daily use of medications with significant CYP2B6 and CYP3A4 inhibition or induction effects that can interfere with metabolism of ketamine
• Advanced cardiopulmonary disorders, including stroke, cardiac arrest, and myocardial infarction in the past year
• History of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation
• \*\*Clinically significant EKG abnormalities.
• Current significant use (>3 days/week) of barbiturates, sedative hypnotics, benzodiazepines, ketamine, or PCP (prescribed or illicit)

• NOTE: Due to time constraints in the study design, these exclusion criteria do not need to be met before the initial consent to participate. This criterion only needs to be established prior to the first ketamine session. Individuals that are initially enrolled and subsequently do not qualify due to severe hepatic impairment will be considered screen failures and withdrawn from the protocol.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Maryland Addiction Programs and Affiliated Clinics — Baltimore

Идентификаторы

NCT: NCT06943859 · HP-00114026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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