NeuroControl of Nicotine Dependence
Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
October 1, 2024
September 1, 2024
5.5 years
March 20, 2024
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute effects of cTBS on cognitive control
between-arm differences in neurocognitive task performance as measured by percent correct on an inhibitory control task and self reported craving on a regulation of craving task.
1 hour after receiving cTBS
Secondary Outcomes (1)
Exploratory: Acute effects of cTBS on fMRI brain response
1 hour after receiving cTBS
Other Outcomes (1)
Safety and Tolerability
24 hours following receipt of cTBS
Study Arms (3)
cTBS to Ventrolateral Prefrontal Cortex
EXPERIMENTALContinuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the ventrolateral prefrontal cortex.
cTBS to Dorsomedial Prefrontal Cortex
EXPERIMENTALContinuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the dorsomedial prefrontal cortex.
cTBS to Vertex
EXPERIMENTALContinuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the vertex.
Interventions
Continuous theta burst rTMS
Eligibility Criteria
You may qualify if:
- Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
- English Fluency
- Functional Vision (with corrective lenses as needed)
You may not qualify if:
- Use of psychotropic and antiepileptic medications in the last month
- Presence of an untreated illness or serious medical condition
- History of major neurological illness
- Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 min., implanted electronic device, metal in the head) or MRI.
- Any use of substances that lower seizure threshold.
- Current or past psychosis
- Electroconvulsive therapy in the past 6 months
- Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
- BAC greater than 0.0.
- Positive urine pregnancy test
- Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Neuroscience Center
Columbia, Missouri, 65203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 20, 2024
First Posted
April 4, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
March 25, 2030
Study Completion (Estimated)
April 30, 2030
Last Updated
October 1, 2024
Record last verified: 2024-09