N/A
N=23
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
Opioid-use Disorder · Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05049460 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Attentional Bias for Smoking Stimuli — 501.53; 406.70 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Theta Burst Stimulation (Device); Sham TMS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gopalkumar Rakesh
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attentional Bias for Smoking Stimuli |
275.83; 414.52 | — |
| PRIMARY Attentional Bias for Smoking Stimuli |
275.83; 414.52 | — |
| PRIMARY Attentional Bias for Opioid Stimuli |
305.80; 158.61 | — |
| PRIMARY Attentional Bias for Opioid Stimuli |
305.80; 158.61 | — |
| PRIMARY Craving |
54.1; 48.7 | — |
| PRIMARY Craving |
54.1; 48.7 | — |
| SECONDARY Number of Participants Showing Functional Connectivity Changes |
7; 7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05049460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.