Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

NCT ID: NCT05049460

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2024-07-31

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.

Detailed Description

Tobacco use disorder (TUD) is highly comorbid with opioid use disorder (OUD). Craving in TUD as well as OUD is of two kinds - phasic and tonic. Phasic craving is present at baseline and tonic craving is accentuated by environmental stimuli. A predominant mediator of tonic craving is attentional bias (AB) for environmental stimuli related to either smoking or opioid use.

The study is comprised of two days of participation. On the first day, participants will perform two attentional bias (AB) paradigms - one to assess their baseline AB for smoking cues versus neutral cues and another AB paradigm to assess baseline AB for opioid cues versus neutral cues. Craving will be assessed using tobacco craving questionnaire and a visual analogue scale (for opioids), in the context of participants performing a stress induction procedure (which will be a combination of the cold pressor test and PASAT). The investigators will also acquire a baseline resting state fMRI in addition to MRPAGE structural T1 and T2W sequences.

On the second day, participants will receive either four sessions of TBS or sham TMS. Targeting will be down using processed resting state brain scan. Each session of TBS or sham TMS will last approximately 10 minutes. During each of the 50 minute intervals between stimulation sessions, participants will perform AB paradigms for smoking and opioids. The craving scale with stress induction will be performed twice - once before the sessions and once after the four sessions of TBS/sham TMS. The investigators will also acquire resting state scans after the four sessions of TBS/sham TMS.

Conditions

Opioid-use Disorder; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Theta Burst Stimulation

Intervention Type: DEVICE

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.

Group Type: PLACEBO_COMPARATOR

Sham TMS

Intervention Type: DEVICE

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

Interventions

Theta Burst Stimulation

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients enrolled in the SMART Clinic at University of Kentucky
• 18-60 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Craig Rush, PhD

Role: STUDY_CHAIR

Professor, Department of Behavioral Sciences

Locations

245 Fountain Court

Lexington, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37693107 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

56570

Identifier Type: -

Identifier Source: org_study_id