NeuroControl of Nicotine Dependence

September 30, 2024 updated by: Brett Froeliger, University of Missouri-Columbia

Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cTBS to Ventrolateral Prefrontal Cortex
Continuous 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous theta burst rTMS
Other Names:
  • cTBS
Experimental: cTBS to Dorsomedial Prefrontal Cortex
Continuous 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous theta burst rTMS
Other Names:
  • cTBS
Experimental: cTBS to Vertex
Continuous 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous theta burst rTMS
Other Names:
  • cTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effects of cTBS on cognitive control
Time Frame: 1 hour after receiving cTBS
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Acute effects of cTBS on fMRI brain response
Time Frame: 1 hour after receiving cTBS
between-arm differences in whole brain fMRI BOLD functional connectivity. Neural network connectivity will be characterized using rZ values.
1 hour after receiving cTBS

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 24 hours following receipt of cTBS
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

March 25, 2030

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 403690

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicotine Dependence

Clinical Trials on Repetitive Transcranial Magnetic Stimulation (rTMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe