Trial Outcomes & Findings for Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder (NCT NCT05049460)

Results Overview

Attentional bias was measured at baseline using a visual probe task administered (adapted for smoking images) on a computer and an eye tracker. Images of cigarettes and matched neutral images were presented on a laptop screen, 3 cm apart. Upon offsetting the image pairs, a visual probe (X) appeared on either the left or right side of the screen, in the exact location of one of the previously presented images. Attentional bias is quantified by subtracting the average fixation time on neutral cues from the average fixation time on cigarette cues. The fixation time is measured with an eye tracker in milliseconds.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Baseline

Results posted on

2025-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Active Intervention Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Overall Study STARTED	12	11
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Intervention Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.13 years STANDARD_DEVIATION 10.97 • n=5 Participants	35.43 years STANDARD_DEVIATION 5.16 • n=7 Participants	36.87 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Attentional bias was measured at baseline using a visual probe task administered (adapted for smoking images) on a computer and an eye tracker. Images of cigarettes and matched neutral images were presented on a laptop screen, 3 cm apart. Upon offsetting the image pairs, a visual probe (X) appeared on either the left or right side of the screen, in the exact location of one of the previously presented images. Attentional bias is quantified by subtracting the average fixation time on neutral cues from the average fixation time on cigarette cues. The fixation time is measured with an eye tracker in milliseconds.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Attentional Bias for Smoking Stimuli	501.53 milliseconds Standard Error 145.24	406.70 milliseconds Standard Error 116.41

PRIMARY outcome

Timeframe: Immediately after intervention (sessions of TBS or sham TMS)

Attentional bias was measured using a visual probe task administered (adapted for smoking images) on a computer and an eye tracker. Images of cigarettes and matched neutral images were presented on a laptop screen, 3 cm apart. Upon offsetting the image pairs, a visual probe (X) appeared on either the left or right side of the screen, in the exact location of one of the previously presented images. Attentional bias is quantified by subtracting the average fixation time on neutral cues from the average fixation time on cigarette cues. The fixation time is measured with an eye tracker in milliseconds.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Attentional Bias for Smoking Stimuli	275.83 milliseconds Standard Error 158.14	414.52 milliseconds Standard Error 254.3

PRIMARY outcome

Timeframe: Baseline

Attentional bias was measured using a visual probe task administered (adapted for opioid images) on a computer and an eye tracker. Images of opioids and matched neutral images were presented on a laptop screen, 3 cm apart. Upon offsetting the image pairs, a visual probe (X) appeared on either the left or right side of the screen, in the exact location of one of the previously presented images. Attentional bias is quantified by subtracting the average fixation time on neutral cues from the average fixation time on opioid cues. The fixation time is measured with an eye tracker in milliseconds.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Attentional Bias for Opioid Stimuli	373.09 milliseconds Standard Error 176.06	132.01 milliseconds Standard Error 70.89

PRIMARY outcome

Timeframe: Immediately after intervention (sessions of TBS or sham TMS)

Attentional bias was measured using a visual probe task administered (adapted for opioid images) on a computer and an eye tracker. Images of opioids and matched neutral images were presented on a laptop screen, 3 cm apart. Upon offsetting the image pairs, a visual probe (X) appeared on either the left or right side of the screen, in the exact location of one of the previously presented images. Attentional bias is quantified by subtracting the average fixation time on neutral cues from the average fixation time on opioid cues. The fixation time is measured with an eye tracker in milliseconds.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Attentional Bias for Opioid Stimuli	305.80 milliseconds Standard Error 196.95	158.61 milliseconds Standard Error 198.75

PRIMARY outcome

Timeframe: Baseline

The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Craving	57.8 units on a scale Standard Error 5.3	53.1 units on a scale Standard Error 6.1

PRIMARY outcome

Timeframe: Immediately after intervention (sessions of TBS or sham TMS)

The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.

Outcome measures

Outcome measures
Measure	Active Intervention n=8 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Craving	54.1 units on a scale Standard Error 6.3	48.7 units on a scale Standard Error 4.9

SECONDARY outcome

Timeframe: Baseline and immediately after intervention (sessions of TBS or sham TMS)

Changes in resting state network changes caused by TBS/sham TMS

Outcome measures

Outcome measures
Measure	Active Intervention n=7 Participants Four sessions of theta burst stimulation, amounting to 7200 pulses at 120% resting motor threshold. Targeting will be done using neuronavigation and processed resting state brain scan. Theta Burst Stimulation: Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.	Sham TMS n=7 Participants Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan. Sham TMS: Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.
Number of Participants Showing Functional Connectivity Changes	7 Participants	7 Participants

Adverse Events

Active Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TMS

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

Gopalkumar Rakesh MD

University of Kentucky, Lexington

Phone: 859-257-9402

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place