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NIH grant 1R21DA065852-01: Low-dose ketamine for the treatment of opioid use disorder
Institute: {'code': 'DA', 'abbreviation': 'NIDA', 'name': 'National Institute on Drug Abuse', 'admin_org_id': '12500072', 'admin_funding_url': ''}. PI: Peter Manza. Award: $233250.
Start: 2026-09-30T00:00:00.
PROJECT SUMMARY
Opioid use disorder (OUD) remains a public health crisis. First-line pharmacological treatments for OUD
include methadone, which decreases drug use and improves mental and physical health. At treatment onset it
takes weeks to titrate up to a final effective methadone dose, and during this time individuals experience
distressing withdrawal symptoms, especially craving, negative affect, insomnia, and chronic pain. These
symptoms alter decision making and motivate drug use to relieve the aversive state. As such, treatment
cessation rates are high with most dropouts occurring in the first three months; previous research has identified
three months as the minimum amount of time necessary to achieve positive long-term outcomes. This presents
an urgent need to develop adjunctive interventions that reduce OUD symptom severity during the initial weeks
of methadone treatment.
In this high-risk, high-reward R21 clinical trial, we aim to test the initial efficacy and feasibility of a brief
ketamine treatment regimen for individuals initiating methadone therapy at the University of Maryland,
Baltimore (UMB). Participants (n=30) entering methadone treatment will be randomized in a double-blind
manner to receive either a low dose (0.75 mg/kg) or a very low dose (0.1 mg/kg, a minimally psychoactive
control) of intramuscular ketamine administered four times over two weeks. We will assess changes in opioid
craving (primary endpoint), along with secondary outcomes including mood, sleep, pain, decision-making
behaviors, treatment adherence, and drug use, over three months. Additionally, clinician perceptions of
ketamine as a potential adjunctive OUD therapy will be evaluated for acceptability and feasibility. These
endpoints will provide critical preliminary data to refine future larger-scale trials.
This innovative approach, leveraging ketamine's established pharmacology and rapid clinical effects, targets a
critical period (the initial weeks of methadone treatment) during which symptom severity and dropout risk are
highest. The results from this study will provide critical preliminary data to inform larger trials, potentially
introducing a transformative, cost-effective adjunctive treatment option that significantly enhances OUD
treatment outcomes.document fetched 2026-10-20 02:44