오피오이드 사용 장애를위한 케타민

실험적: 케타민 치료

개인은 2 주 동안 0.75mg/kg의 근육 내 케타민 (n = 25)의 1-6 일 간격으로 4 가지 복용량을 받게됩니다.

의약품: 케타민 치료

참가자는 2 주 동안 0.75 mg/kg 내 근육 케타민 (n = 25)의 1-6 일 간격으로 4 회량의 케타민 간격을 받게됩니다 (첫 번째 케타민 세션은 28 일 이내에 발생해야 함). 개인은 임상의가 복용 후 2 시간 동안 모니터링됩니다.

활성 비교기: 매우 낮은 용량의 케타민 치료

개인들은 2주 동안 근육 내 케타민(0.1mg/kg)을 1-6일 간격으로 4회 투여받게 됩니다(n=25).

의약품: 매우 저용량 케타민 치료

참가자는 2주 동안 1-6일 간격으로 매우 낮은 용량의 케타민(0.1mg/kg) 4회 투여(n=25)를 받게 됩니다(첫 번째 케타민 세션은 등록 후 28일 이내에 진행되어야 함). 참가자는 투여 후 2시간 동안 임상의의 모니터링을 받게 됩니다.

Tonic craving (FORCAST) total scores

Faceted Opioid Research Craving Assessment for Substance use Treatment (FORCAST): A 26-item assessment of tonic craving that the person reports having felt over the prior one or two weeks. Participants indicate how much they disagree or agree with each statement on a scale that ranges from 0-6, with 0 representing "strongly disagree", 3 representing "neither agree nor disagree", and 6 representing "strongly agree". Higher scores indicate higher levels of craving. The minimum score is 0, and the maximum scores for each of the subscales are as follows:

Preoccupation: 24 Negative Reinforcement: 30 Positive Reinforcement: 24 Motivation: 30 Lack of control: 24 Uneasiness: 24

Maximum total score for all subscales = 156

Severity of depression symptoms

Montgomery-Asberg Depression Rating Scale (MADRS): a 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Item 10 on the instrument will be used to monitor any changes in suicidal ideation throughout the trial.

Cue-induced craving scores

Cue Reactivity Paradigm: our drug cue reactivity paradigm will be designed to elicit an acute craving state. We will present a series of opioid cue images continuously (total time <5 min) via computer or tablet. Cues will be personalized based on each individual's drug use history as derived from baseline clinical assessments. For example, if a participant had no history of intravenous drug injection, we will not present opioid cue images containing injection paraphernalia like needles and instead will present images with opioid pills and/or powder. At the end of each one-minute session, participants will be asked to rate, on a scale of 1-10, "How much did you like the images you saw?", "How much do you want to use right now?", "How much do you want to avoid using right now?", "How much control do you feel you have over using right now" and "What is the maximum amount you would pay right now for a single dose of what you saw?"

Chronic pain ratings

Graded Chronic Pain Scale (GCPS): a six-item instrument that evaluates chronic pain severity (intensity and impact on life activities).

Number of methadone doses received at 90 days post final ketamine session

Study team will have access to clinic records to assess the number of methadone doses patients have received at 90 days post final ketamine session

Sleep quality ratings

Pittsburgh Sleep Quality Index (PSQI): A 19-item questionnaire assessing past-month sleep quality and disturbances. Seven component scores are generated: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the 7 components yields one global score

Insomnia Symptoms

Insomnia Severity Index (ISI): A five-item measure of current (past two weeks, or since last study visit) insomnia symptoms.

Sleep quality ratings on a Visual Analogue Scale (VAS)

Modified Single Item Sleep Quality Scale (SQS): A self-administered questionnaire that incorporates a VAS delivered electronically. SQS directs the patient to rate the overall quality of sleep over a 7-day period (modified for our study to rate the overall quality of sleep the past night) on a scale of 1-10 considering how many hours of sleep they had, how easily they fell asleep, how often they woke up during the night (excluding bathroom trips), how often they woke up earlier than intended

Scores on a holistic measure of recovery

Substance Use Recovery Evaluator (SURE): A 21-item patient reported outcome measure of recovery from substance use disorder that has good face and content validity, acceptability and usability for people in recovery and is psychometrically valid.

Frequency of negative urine drug screens through 90 days post final ketamine session

Study team will have access to clinic drug screenings through 90 days post-intake

Decision making test performance (risk and ambiguity tolerance)

Choice under risk and ambiguity (CRA) decision making task: On each trial, participants choose between a guaranteed $1 and a lottery. Each lottery has 2 possible outcomes: v or $0, where v ranges from $1.20 to $13.20. On half of the trials, v could be received with 1 of 3 known probabilities (p: 25%, 50%, or 75%); on the other half, the probability information is occluded and thus incompletely known (the ambiguity context). There are 3 levels of ambiguity: low (24% unknown), medium (50% unknown), and high (74% unknown). In reality, the true underlying probability in ambiguity trials is fixed at 50%. Different combinations of v, risk level, and ambiguity level are presented for 30 trials total.

A modified utility model will be used which can extract the following parameters from participant decisions on these trials:

• risk tolerance
• ambiguity tolerance
• choice stochasticity

Methadone dose (mg) at 90 days post final ketamine session

Study team will have access to clinic records of methadone dose (mg) received by participant at 90 days post final ketamine session

OUD treatment outcomes at 6-, 9-, and 12 months post study enrollment

Study team will have access to clinic records of methadone dose, number of methadone doses received, and frequency of negative drug screens though 12 months post study enrollment