Clinical trial NCT05049460: Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
Official title: Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Tobacco Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Attentional bias for smoking stimuli
timeFrame: Baseline
measure: Attentional bias for smoking stimuli
timeFrame: Immediately after intervention (sessions of TBS or sham TMS)
measure: Attentional bias for opioid stimuli
timeFrame: Baseline
measure: Attentional bias for opioid stimuli
timeFrame: Immediately after intervention (sessions of TBS or sham TMS)
measure: Craving
timeFrame: Baseline
measure: Craving
timeFrame: Immediately after intervention (sessions of TBS or sham TMS)
Secondary outcomes:
measure: Functional connectivity changes
timeFrame: Baseline
measure: Functional connectivity changes
timeFrame: Immediately after intervention (sessions of TBS or sham TMS)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 245 Fountain Court
state: Kentucky
Study officials:
affiliation: Professor, Department of Behavioral Sciences
name: Craig Rush, PhD
role: STUDY_CHAIR
References: