Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

Tobacco Use Disorder Clinical Trial

Official title:

Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049460
• Other study ID #: 56570
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: Gopalkumar Rakesh, MD
• Phone: 857-222-2276
• Email: gopalkumar.rakesh[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impulsive Behavior
• Opioid-Related Disorders
• Opioid-use Disorder
• Tobacco Use Disorder

Intervention

Device:
• 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, done using the A/P MagVenture coil, with subject's head separated from the coil by foam padding.

Locations

Country	Name	City	State
United States	245 Fountain Court	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Gopalkumar Rakesh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attentional bias for smoking stimuli	Measured using visual probe task administered (adapted for smoking images) on a computer and eye tracker	Baseline
Primary	Attentional bias for smoking stimuli	Measured using visual probe task administered (adapted for smoking images) on a computer and eye tracker	Immediately after intervention (sessions of TBS or sham TMS)
Primary	Attentional bias for opioid stimuli	Measured using visual probe task administered (adapted for opioid images) on a computer and eye tracker	Baseline
Primary	Attentional bias for opioid stimuli	Measured using visual probe task administered (adapted for opioid images) on a computer and eye tracker	Immediately after intervention (sessions of TBS or sham TMS)
Primary	Craving	Measured using tobacco craving questionnaire	Baseline
Primary	Craving	Measured using tobacco craving questionnaire	Immediately after intervention (sessions of TBS or sham TMS)
Secondary	Functional connectivity changes	Changes in resting state network changes caused by TBS/sham TMS	Baseline
Secondary	Functional connectivity changes	Changes in resting state network changes caused by TBS/sham TMS	Immediately after intervention (sessions of TBS or sham TMS)