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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05049460
Study type Interventional
Source University of Kentucky
Contact Gopalkumar Rakesh, MD
Phone 857-222-2276
Email gopalkumar.rakesh@uky.edu
Status Recruiting
Phase N/A
Start date September 15, 2021
Completion date July 31, 2024

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