Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

Prior treatment

• Significant prior use of ketamine for non-anesthetic purposes, as determined by the investigators
• Taking any prohibited medications
• If receiving any medication that may cause blunting of responses or diminished affect, such as antipsychotics, exclusion will be as per the evaluation of the PI and study staff
• Taken another investigational drug in the past 30 days

Other illness

• Cognitive impairment sufficient to impede the ability to complete study tasks
• Lifetime history of intracranial hemorrhage
• Had a stroke in the past 12 months
• Had a seizure in the past 6 months
• Has current psychosis or any lifetime history of schizophrenia or schizoaffective disorder
• Baseline hypertension (≥150 SBP or ≥90 DBP) after repeated measurements
• History of aneurysmal vascular disease, dissection or arteriovenous malformation
• Had a cardiac arrest or myocardial infarction in the past 12 months
• Has a clinically significant arrhythmia
• Has any physical or mental health condition which, per the clinical judgment of the investigators, interferes with safe study participation or adherence to study procedures

Lab values

• QTc \>450 msec on 12-lead EKG (Bazett's formula)
• Meets any of the following laboratory parameters: ALT ≥3x ULN, AST ≥3x ULN, total bilirubin ≥1.5x ULN, eGFR \<30mL/min by CKD-EPI or currently on dialysis

Other

• Has an intracranial mass
• Engaged in a contingency management program during study
• Active suicidal ideation with intent
• Pregnant, breastfeeding, or unwilling to use birth control during the study
• Pending legal proceedings with a high risk for incarceration during the study

• Age 18-69
• Moderate or severe methamphetamine use disorder
• Interest in reducing or stopping methamphetamine use
• Insured by MediCal, MediCare, or Healthy San Francisco
• Used methamphetamine ≥7 out of the 30 days prior to screening OR enrolled in a residential drug treatment program
• Have a diagnosis of HIV OR taken PrEP over the last 90 days OR engaged in ≥1 risk behavior for HIV acquisition/transmission over the last 90 days (i.e., anal sex under the influence of methamphetamine, condomless sex with a partner of serodiscordant or unknown HIV status, or any shared use of injection drug supplies)
• English speaking
• Permanently housed for ≥30 days OR enrolled in residential drug treatment for ≥5 days
• Have a text-capable cell phone or access to email (if not enrolled in residential treatment)
• Able and willing to provide informed consent and adhere to visit schedule
• If necessary, willing to be contacted on a daily basis by one of the therapists for 7 days after each ketamine session
• Prior to scheduled ketamine sessions, agree: (a) abstain from using methamphetamine and cocaine for ≥48 hours, (b) abstain from using non-prescribed opioids, cannabis products, benzodiazepines, or alcohol for ≥24 hours, (c) consume no more than a modest quantity (e.g., 1 cup) of caffeine (e.g., coffee or tea) in the morning; (d) continue usual regimen of routinely prescribed opioid-based medications throughout trial; and (e) continue any routine behavioral or pharmacologic mental health interventions as usual outside of the trial
• Female-born participants of child-bearing potential with male-born partners and male-born participants with female-born partners of child-bearing potential must agree to use highly effective contraception for at least 1 month prior to and 2 months after ketamine administration