Trial Outcomes & Findings for Neurocircuit Strategy to Decrease Cocaine Cue Reactivity (NCT NCT04155632)

Last Updated: 2025-09-24

Results Overview

Measured using fMRI during cocaine cue reactivity task. Percent BOLD signal change in OFC from baseline (Visit 2) to post-TBS (Visit 3). Measured using functional MRI during a cocaine cue reactivity task. The outcome reflects the change in raw BOLD signal in the orbitofrontal cortex (OFC) between baseline and post-TBS sessions. Signal change was calculated by comparing activation during cocaine-related image blocks versus neutral image blocks. Values are reported as raw BOLD signal units (not percentages).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

From baseline to immediately post-TBS

Results posted on

2025-09-24

Participant Flow

Only 32 were randomized and started treatment.

Participant milestones

Participant milestones
Measure	Active Theta Burst Stimulation Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Sham Theta Burst Stimulation Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Theta Burst Stimulation n=16 Participants Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Sham Theta Burst Stimulation n=16 Participants Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Total n=32 Participants Total of all reporting groups
Age, Continuous	48.3 year STANDARD_DEVIATION 10.5 • n=99 Participants	53.8 year STANDARD_DEVIATION 10.9 • n=107 Participants	51.1 year STANDARD_DEVIATION 10.9 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	14 Participants n=107 Participants	25 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants	11 Participants n=107 Participants	19 Participants n=206 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Cocaine Craving Rating	4.39 score on a scale STANDARD_DEVIATION 2.04 • n=99 Participants	4.45 score on a scale STANDARD_DEVIATION 1.98 • n=107 Participants	4.42 score on a scale STANDARD_DEVIATION 1.98 • n=206 Participants
Profile of Mood States (POMS)	23.50 POMS score STANDARD_DEVIATION 34.86 • n=99 Participants	18.75 POMS score STANDARD_DEVIATION 30.95 • n=107 Participants	21.13 POMS score STANDARD_DEVIATION 32.52 • n=206 Participants
OFC brain activity	0.0049 Percent BOLD signal change STANDARD_DEVIATION 0.0096 • n=99 Participants	-0.0012 Percent BOLD signal change STANDARD_DEVIATION 0.0102 • n=107 Participants	0.0018 Percent BOLD signal change STANDARD_DEVIATION 0.0102 • n=206 Participants

PRIMARY outcome

Timeframe: From baseline to immediately post-TBS

Outcome measures

Outcome measures
Measure	Active Theta Burst Stimulation n=16 Participants Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Sham Theta Burst Stimulation n=16 Participants Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.
Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)	-0.0026 BOLD signal Standard Deviation 0.0080	0.0007 BOLD signal Standard Deviation 0.0105

PRIMARY outcome

Timeframe: From baseline to immediately post-TBS

Total POMS score measured before and after TBS. Higher scores indicate worse mood.

Outcome measures

Outcome measures
Measure	Active Theta Burst Stimulation n=16 Participants Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Sham Theta Burst Stimulation n=16 Participants Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.
Change in POMS Score From Baseline to Post-TBS"	5.53 POMS score Standard Deviation 27.58	14.63 POMS score Standard Deviation 23.32

PRIMARY outcome

Timeframe: From baseline to immediately post-TBS

Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving.

Outcome measures

Outcome measures
Measure	Active Theta Burst Stimulation n=16 Participants Two trains of 120-second active cTBS consisted of 3-pulse bursts delivered at 5 Hz.	Sham Theta Burst Stimulation n=16 Participants Two trains of 120-second sham cTBS consisted of 3-pulse bursts delivered at 5 Hz.
Change in Cocaine Craving Rating From Baseline to Post-TBS	3.31 score on a scale Standard Deviation 2.32	3.99 score on a scale Standard Deviation 2.43

Adverse Events

Active Theta Burst Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Theta Burst Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Xiaolong Peng

Medical University of South Carolina

Phone: 8437928642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place