NeuroControl of Nicotine Dependence

Nicotine Dependence Clinical Trial

Official title:

Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347055
• Other study ID #: 403690
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 30, 2030

Study information

• Verified date: April 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2030
• Est. primary completion date: March 25, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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

2. English Fluency

3. Functional Vision (with corrective lenses as needed)

Exclusion Criteria:

1. Use of psychotropic and antiepileptic medications in the last month

2. Presence of an untreated illness or serious medical condition

3. History of major neurological illness

4. 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.

5. Any use of substances that lower seizure threshold.

6. Current or past psychosis

7. Electroconvulsive therapy in the past 6 months

8. Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea

9. BAC greater than 0.0.

10. Positive urine pregnancy test

11. Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous theta burst rTMS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and Tolerability	Safety and tolerability of cTBS administered to each cortical location, as measured by self reported side effects on a review of symptoms questionnaire.	24 hours following receipt of cTBS
Primary	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	Exploratory: Acute effects of cTBS on fMRI brain response	between-arm differences in whole brain fMRI BOLD functional connectivity. Neural network connectivity will be characterized using rZ values.	1 hour after receiving cTBS