Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2021-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transcranial Direct Current Stimulation - Tobacco Use Disorder

NCT03691805

Tobacco Use Disorder

COMPLETED NA

Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

NCT03841292

Tobacco Dependence Smoking Cessation Tobacco Smoking +4 more

COMPLETED NA

Nicotine Patch Pretreatment for Smoking Cessation in PTSD

NCT00625131

Stress Disorders, Posttraumatic Tobacco Use Disorder

COMPLETED EARLY_PHASE1

Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder

NCT02776319

Tobacco Use Disorder

UNKNOWN NA

Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)

NCT04209153

Adults (Male and Female Subjects) With Tobacco Dependence

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent Theta-burst stimulation (iTBS)

Cross-over design - participants will receive both experimental treatments.

Group Type EXPERIMENTAL

Intermittent Theta-burst stimulation (iTBS)

Intervention Type DEVICE

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Continuous Theta-burst stimulation (cTBS)

Intervention Type DEVICE

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.

Continuous Theta-burst stimulation (cTBS)

Cross-over design - participants will receive both experimental treatments.

Group Type EXPERIMENTAL

Intermittent Theta-burst stimulation (iTBS)

Intervention Type DEVICE

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Continuous Theta-burst stimulation (cTBS)

Intervention Type DEVICE

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermittent Theta-burst stimulation (iTBS)

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Intervention Type DEVICE

Continuous Theta-burst stimulation (cTBS)

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Be between the ages of 18 and 65.
2. Be in stable mental and physical health.
3. Be willing to provide informed consent.
4. Be able to comply with protocol requirements and likely to complete all study procedures.
5. Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.

Exclusion Criteria

* 1\. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).

2\. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy, as indicated by a positive urine pregnancy test at screening).

3\. Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).

4\. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.

5\. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.

6\. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.

7\. BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes