Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks
Bibliographic record
Abstract
INTRODUCTION: Methamphetamine use disorder (MeUD) is a debilitating condition with no FDA-approved pharmacotherapies that has been associated with poor neurological, psychiatric and cardiovascular outcomes, particularly among low-income populations. The use of methamphetamine also increases risks for sexually transmitted infections (STIs) by reducing behavioural inhibitions while enhancing sexual libido, disproportionately affecting sexual and gender minorities. The overlap of MeUD with HIV risks and psychological trauma underscores the need for innovative, accessible and culturally responsive therapies. Ketamine-assisted psychotherapy (KAP), which has shown promise for treatment-resistant depression and other substance use disorders, has yet to be explored for MeUD. The Ketamine-Assisted Recovery (KARE) trial seeks to address this gap. METHODS AND ANALYSIS: KARE is an open-label pilot study enrolling N=12-24 Medicaid-insured or Medicare-insured adults with moderate-to-severe MeUD and HIV risk factors. Participants will undergo three office-based intramuscular ketamine (0.50-0.75 mg/kg) sessions in combination with seven sessions of motivational enhancement therapy over 5 weeks. Recruitment efforts target community-based organisations, outpatient clinics offering HIV and STI testing/treatment, and substance use disorder treatment programmes. Feasibility, acceptability and tolerability will be assessed via recruitment and a priori retention benchmarks, surveys and semistructured interviews exploring participants' perceptions of KAP and ketamine's misuse potential. Safety will be evaluated through systematic monitoring for adverse events and serial measurement of vital signs during dosing., craving, withdrawal, HIV risk behaviours and psychological distress, as well as psychological and cognitive flexibility as potential mechanisms of ketamine's effects, laying the groundwork for future randomised controlled trials. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of California, San Francisco Institutional Review Board (24-41588) and the Research Advisory Panel of California (202422S). Results will be disseminated through national conferences, peer-reviewed publications and presentations to community-based stakeholders. TRIAL REGISTRATION NUMBER: NCT06538285.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.014 | 0.012 |
| Meta-epidemiology (narrow) | 0.004 | 0.003 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.005 | 0.008 |
| Insufficient payload (model declined to judge) | 0.067 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".