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Evaluating the Efficacy of Medial Prefrontal Cortex Accelerated Theta-Burst Stimulation for Cocaine Use Disorder: A Human Laboratory Inpatient Study

Award Number: R01DA066804
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Evaluating the Efficacy of Medial Prefrontal Cortex Accelerated Theta-Burst Stimulation for Cocaine Use Disorder: A Human Laboratory Inpatient Study - ABSTRACT Cocaine use disorder (CUD) is a persistent public health problem and existing treatments are insufficient. The overarching goal of the present project is to address this need by evaluating the initial efficacy of a novel accelerated transcranial magnetic stimulation (TMS) protocol for CUD. TMS is FDA-approved for certain psychiatric disorders and might be effective for CUD. However, the duration of TMS treatment is typically 3-6 weeks, which could be a barrier to the implementation in people with CUD (pwCUD). Accelerated TMS protocols, which are characterized by multiple sessions of stimulation per day over condensed timeframes, offer the potential for rapid therapeutic effects. The medial prefrontal cortex (mPFC) plays a critical role in decision-making, cue reactivity and drug reward. Our preliminary work found that cocaine cues biased decisions in pwCUD and that activity in the mPFC was significantly correlated with the subjective value of cocaine but not neutral cues. Several previous trials have targeted the mPFC of pwCUD with continuous theta- burst stimulation (cTBS, inhibitory) and found promising results, though the effects on some relevant measures were of small magnitude and not always statistically significant relative to sham treatment across studies. The proposed project will advance these promising initial findings by testing a novel accelerated cTBS (acTBS) protocol that will administer the largest TMS dose (43,200 pulses) to the mPFC in pwCUD to date, during 3 sessions/day for 4 days, which is anticipated to be safe and well tolerated, but produce larger effects on laboratory measures of efficacy than previous research. To this end, forty-four (n=44 total; n=22/group) adult participants aged 18–55 with moderate/severe CUD will complete a randomized, double-blind, sham- and placebo-controlled group trial. After outpatient screening and orientation, subjects are assigned to a novel acTBS group condition and admitted as inpatients. Prior to, and following, the acTBS intervention, subjects will complete measures of efficacy including cocaine-cued concurrent monetary choice and craving tasks during fMRI scanning, and cocaine demand and subjective effects tasks following intranasal cocaine dosing (0, 20, 40 and 60 mg), as well as safety/tolerability measures. This proposal aligns with several areas of interest at NIDA by proposing a novel target (mPFC) for accelerated cTBS, assessing behavioral and clinical outcomes that characterize CUD, and including neuroimaging to determine the effects on large-scale brain networks and specific circuits. Positive findings will advance TMS as a treatment for CUD and increase our understanding of the mechanisms by which it produces its beneficial effects in pwCUD.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $721,097 )
2026	2026	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Drug Use and Addiction Research Programs	001	1	8/11/2026	NEW	$0
2026	2026	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Drug Use and Addiction Research Programs	000	1	8/7/2026	NEW	$721,097
														Subtotal = $721,097

Grand Total All Awards = $721,097

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Evaluating the Efficacy of Medial Prefrontal Cortex Accelerated Theta-Burst Stimulation for Cocaine Use Disorder: A Human Laboratory Inpatient Study

Award Number: R01DA066804

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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