Ketamine for Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Interventions
- Drug: Treatment with KetamineDrug: Treatment with Active Placebo
- Registration Number
- NCT06943859
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
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 ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo?
Researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects 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 ketamine or a placebo 4 times over a period of 2 weeks
* Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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 14 days at the time of screening.
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Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake. Source: Self-report, H&P
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Recent prescribed or illicit benzodiazepine, ketamine, or PCP use that exceeds 5+ days/week for the last 3 months. Source: H&P
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Pregnant and/or breastfeeding. Source: UDS, H&P
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Stage 4 Hypertension, defined by a systolic blood pressure (SBP) > 180 mmHg or a diastolic blood pressure (DBP) > 120 mmHg. Source: H&P
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Clinically significant abnormal findings for which study participation is deemed unsafe. Source: H&P
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Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder). Source: H&P
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**Severe hepatic impairment (baseline alkaline phosphatase or aspartate aminotransferase > 5 times the upper limit of normal. Source: Labs
- NOTE: Due to time constraints in the study design, exclusion criterion #7 does not need to be met before the initial consent to participate. This criterion only needs to be established prior to the first esketamine/placebo session. This will allow us to enroll participants as soon as possible, giving more time and flexibility to complete the baseline/weekly assessments before the first esketamine/placebo 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment with Ketamine Treatment with Ketamine Individuals will receive four doses spaced 1-6 days apart of 0.75mg/kg of intramuscular ketamine (n=25) over a period of two weeks. Treatment with Placebo Treatment with Active Placebo Individuals will receive four doses spaced 1-6 days apart of an intramuscular active placebo (diphenhydramine, 50 mg) (n=25) over a period of two weeks.
- Primary Outcome Measures
Name Time Method Tonic craving (FORCAST) total scores Collected at baseline, weekly, 30-, 60-, and 90 days post-intake 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
- Secondary Outcome Measures
Name Time Method Insomnia Symptoms ISI collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake Insomnia Severity Index (ISI): A five-item measure of current (past two weeks, or since last study visit) insomnia symptoms.
Severity of depression symptoms Completed at baseline, weekly, 30-, 60-, and 90 days post-intake 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 Collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake 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 Collected at Baseline, weekly following intake, 30-, 60-, and 90 days post-intake Pain Brief Scale (PEG): A 3-item measure of past-week average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).
Number of methadone doses received at 90 days post-intake Collected through 90 days post-intake Study team will have access to clinic records to assess the number of methadone doses patients have received at 90 days post-intake
Sleep quality ratings PSQI collected at Baseline and 30-, 60-, and 90 days post-intake 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
Sleep quality ratings on a Visual Analogue Scale (VAS) SQS collected via daily optional EMAs through 90 days post-intake 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 Collected at baseline and at 30-, 60-, and 90 days post-intake 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-intake collected through 90 days post-intake Study team will have access to clinic drug screenings through 90 days post-intake
Trial Locations
- Locations (1)
University of Maryland Addiction Programs and Affiliated Clinics
🇺🇸Baltimore, Maryland, United States