Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
Completed · Not applicable · Has a placebo group
Conditions studied: Opioid-use Disorder, Tobacco Use Disorder
In brief
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.
Key facts
- Study ID
- NCT05049460
- Run by
- Gopalkumar Rakesh
- People needed
- 23
- Starts
- 2021-09-15
- Expected to finish
- 2024-07-31
- Last updated by the study team
- 2025-10-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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.
Where it is running
- 245 Fountain Court — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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