Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

NCT05049460 | Completed Results FDA Device

• 1 other identifier: 56570
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine the effect of four sessions of theta burst stimulation (TBS) versus sham TMS on attentional bias for smoking and opioid cues versus neutral stimuli in a population of patients with tobacco use disorder (TUD) with comorbid opioid use disorder (OUD) that is stable and on treatment with buprenorphine. The investigators will also examine the effect of TBS on craving for cigarettes as well as opioids. Participants will perform a stress induction procedure that mirrors an optimum combination of cues that trigger tonic craving in their environment while exposed to stress. All four sessions of TBS/sham TMS will be performed on the same day, with each session lasting for approximately 10 minutes and separated by 50 minute intervals.

Conditions

Opioid-use Disorder; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (6)

• Attentional Bias for Smoking Stimuli

  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.

  Baseline

• Attentional Bias for Smoking Stimuli

  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.

  Immediately after intervention (sessions of TBS or sham TMS)

• Attentional Bias for Opioid Stimuli

  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.

  Baseline

• Attentional Bias for Opioid Stimuli

  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.

  Immediately after intervention (sessions of TBS or sham TMS)

• Craving

  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.

  Baseline

• Craving

  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.

  Immediately after intervention (sessions of TBS or sham TMS)

Secondary Outcomes (1)

• Number of Participants Showing Functional Connectivity Changes

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

Study Arms (2)

Active intervention

ACTIVE COMPARATOR

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.

Device: Theta Burst Stimulation

Sham TMS

PLACEBO COMPARATOR

Four sessions of sham TMS. Targeting will be done using neuronavigation and processed resting state brain scan.

Device: Sham TMS

Interventions

Theta Burst Stimulation DEVICE

Four sessions of theta burst stimulation (TBS) at 120 % RMT and comprising 7200 pulses, given with functional targeting.

Active intervention

Sham TMS DEVICE

Four sessions of sham TMS, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.

Sham TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients enrolled in the SMART Clinic at University of Kentucky
• years of age
• Preferably right hand dominant
• Currently self-report smoking 10 of more cigarettes per day or a score of \> 5 on the Fagerstrom Test for Nicotine
• Willing and able to abstain from all drug use
• Exhaled breath on day of study CO \< 10 ppm
• Stabilized on maintenance buprenorphine if having comorbid opioid use disorder
• Able to read and speak English
• Able to provide informed consent to participate.

You may not qualify if:

• Pregnant, nursing, or becoming pregnant during the study.
• History of traumatic brain injury or seizures which are contraindications for transcranial magnetic stimulation (TMS).
• Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes which are all contraindications for TMS.
• Presence of intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus nerve stimulation device which are all contraindications for magnetic resonance imaging.
• Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, major neurocognitive disorder, Huntington chorea; multiple sclerosis which are all contraindications for TMS.

Sponsors & Collaborators

• Gopalkumar Rakesh: lead

Study Sites (1)

245 Fountain Court

Lexington, Kentucky, 40513, United States

Location

Related Publications (1)

• Rakesh G, Alcorn JL 3rd, Khanal R, Himelhoch SS, Rush CR. Comparing cigarette-cue attentional bias between people with HIV/AIDS and people with opioid use disorder who smoke. Health Psychol Behav Med. 2023 Sep 7;11(1):2255028. doi: 10.1080/21642850.2023.2255028. eCollection 2023.

  PMID: 37693107 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Gopalkumar Rakesh MD
• Organization: University of Kentucky, Lexington

gopalkumar.rakesh@uky.edu

859-257-9402

Study Officials

• Craig Rush, PhD

  Professor, Department of Behavioral Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 20, 2021
• Study Start: September 15, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)