Tobacco Use DisorderNCT03960138

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

A study testing Intermittent Theta-burst stimulation (iTBS) and Continuous Theta-burst stimulation (cTBS) in people with Tobacco Use Disorder, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use Disorder
What is being tested?: Intermittent Theta-burst stimulation (iTBS) and Continuous Theta-burst stimulation (cTBS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2019to 25 Apr 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be between the ages of 18 and 65.
Be in stable mental and physical health.
Be willing to provide informed consent.
Be able to comply with protocol requirements and likely to complete all study procedures.
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri - Columbia
Columbia, Missouri, 65211

Other trials in United States

About this study

Official title: Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability

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.

Conditions: Tobacco Use Disorder
Being tested: Intermittent Theta-burst stimulation (iTBS), Continuous Theta-burst stimulation (cTBS)
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intermittent Theta-burst stimulation (iTBS)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)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.

Study groups in NCT03960138
Study group	Role	What they receive
Intermittent Theta-burst stimulation (iTBS)	Experimental	Cross-over design - participants will receive both experimental treatments. Receives: Device: Intermittent Theta-burst stimulation (iTBS); Device: Continuous Theta-burst stimulation (cTBS)
Continuous Theta-burst stimulation (cTBS)	Experimental	Cross-over design - participants will receive both experimental treatments. Receives: Device: Intermittent Theta-burst stimulation (iTBS); Device: Continuous Theta-burst stimulation (cTBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment.
Changes in errors of omission on an inhibitory control task performed prior to and immediately after cTBS, and changes in errors of omission on an inhibitory control task performed prior to and immediately after iTBS. Outcomes will be measured as the mean change in behavioral performance percent correct on inhibition trials between baseline and 1 hour post treatment. Scores on the inhibitory control task range from 0% correct to 100% correct, and the change from pre-post TBS is expressed as a percent increase or decrease in performance. Positive values represent an improved outcome, whereas negative values represent a worse outcome.
Measured: 1 hour
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 1 Hour Post Treatment.
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 1 hour post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 1 hour post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
Measured: 1 hour
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 24hrs Post Treatment Between Conditions.
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 24hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 24 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
Measured: 24 hours
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 48hrs Post Treatment Between Conditions.
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 48hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 48 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
Measured: 48 hours
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Hyperdirect Brain Circuit Function Between Pre and Post Session.
Changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after cTBS, and changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after iTBS. Outcomes will be measured as the transformed correlation (rZ value) of BOLD functional connectivity collected during the inhibitory task. The higher the rZ, the better the outcome.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201925 Apr 2021

First posted22 May 2019
Study start26 Sep 2019
Primary completion25 Apr 2021
Study completion25 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03960138
Sponsor's protocol ID: 00074836
Status last verified: Mar 2023
First submitted: 10 May 2019
Last updated: 10 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Froeliger B, McConnell PA, Bell S, Sweitzer M, Kozink RV, Eichberg C, Hallyburton M, Kaiser N, Gray KM, McClernon FJ. Association Between Baseline Corticothalamic-Mediated Inhibitory Control and Smoking Relapse Vulnerability. JAMA Psychiatry. 2017 Apr 1;74(4):379-386. doi: 10.1001/jamapsychiatry.2017.0017.
PubMed 28249070
Upton S, Brown AA, Ithman M, Newman-Norlund R, Sahlem G, Prisciandaro JJ, McClure EA, Froeliger B. Effects of Hyperdirect Pathway Theta Burst Transcranial Magnetic Stimulation on Inhibitory Control, Craving, and Smoking in Adults With Nicotine Dependence: A Double-Blind, Randomized Crossover Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Nov;8(11):1156-1165. doi: 10.1016/j.bpsc.2023.07.014. Epub 2023 Aug 9.
PubMed 37567363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability
ClinicalTrials.gov ID: NCT03960138
Acronym / sponsor ID: 00074836
Conditions: Tobacco Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 26 Sep 2019 (actual)
Primary completion: 25 Apr 2021 (actual)
Study completion: 25 Apr 2021 (actual)
First posted: 22 May 2019 (actual)
Results: Posted 10 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intermittent Theta-burst stimulation (iTBS)	Experimental	Device: Intermittent Theta-burst stimulation (iTBS), Device: Continuous Theta-burst stimulation (cTBS)Cross-over design - participants will receive both experimental treatments.
Continuous Theta-burst stimulation (cTBS)	Experimental	Device: Intermittent Theta-burst stimulation (iTBS), Device: Continuous Theta-burst stimulation (cTBS)Cross-over design - participants will receive both experimental treatments.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be between the ages of 18 and 65.
Be in stable mental and physical health.
Be willing to provide informed consent.
Be able to comply with protocol requirements and likely to complete all study procedures.
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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Continuous Theta-burst stimulation (cTBS), Intermittent Theta-burst stimulation (iTBS)
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.	Device	Continuous Theta-burst stimulation (cTBS), Intermittent Theta-burst stimulation (iTBS)

Primary outcome

The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment.
Time frame: 1 hour
Changes in errors of omission on an inhibitory control task performed prior to and immediately after cTBS, and changes in errors of omission on an inhibitory control task performed prior to and immediately after iTBS. Outcomes will be measured as the mean change in behavioral performance percent correct on inhibition trials between baseline and 1 hour post treatment. Scores on the inhibitory control task range from 0% correct to 100% correct, and the change from pre-post TBS is expressed as a percent increase or decrease in performance. Positive values represent an improved outcome, whereas negative values represent a worse outcome.
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 1 Hour Post Treatment.
Time frame: 1 hour
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 1 hour post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 1 hour post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 24hrs Post Treatment Between Conditions.
Time frame: 24 hours
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 24hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 24 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 48hrs Post Treatment Between Conditions.
Time frame: 48 hours
Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 48hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 48 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Hyperdirect Brain Circuit Function Between Pre and Post Session.
Time frame: 1 hour
Changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after cTBS, and changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after iTBS. Outcomes will be measured as the transformed correlation (rZ value) of BOLD functional connectivity collected during the inhibitory task. The higher the rZ, the better the outcome.

Results and safety

Results posted to the registry on 10 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intermittent Theta-burst Stimulation (iTBS) First	20	16
Continuous Theta-burst Stimulation (cTBS) First	21	21

Primary outcome: The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment.

Time frame: 1 hour. Mean (Standard Error). Unit: Percentage of correct trials

Measure	Intermittent Theta-burst Stimulation (iTBS) n = 37	Continuous Theta-burst Stimulation (cTBS) n = 37
Value	-3.078 (1.560)	3.778 (2.006)

Primary outcome: The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 1 Hour Post Treatment.

Time frame: 1 hour. Mean (Standard Error). Unit: Score on a scale

Measure	Intermittent Theta-burst Stimulation (iTBS) n = 32	Continuous Theta-burst Stimulation (cTBS) n = 32
Value	37.281 (2.191)	34.593 (2.547)

Primary outcome: The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 24hrs Post Treatment Between Conditions.

Time frame: 24 hours. Mean (Standard Error). Unit: Score on a scale

Measure	Intermittent Theta-burst Stimulation (iTBS) n = 32	Continuous Theta-burst Stimulation (cTBS) n = 32
Value	28.656 (2.581)	26.031 (2.071)

Primary outcome: The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 48hrs Post Treatment Between Conditions.

Time frame: 48 hours. Mean (Standard Error). Unit: Score on a scale

Measure	Intermittent Theta-burst Stimulation (iTBS) n = 32	Continuous Theta-burst Stimulation (cTBS) n = 32
Value	29.781 (2.613)	28.968 (2.275)

Adverse events

Time frame: 48 hours post treatment for each condition - baseline, iTBS, cTBS. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intermittent Theta-burst Stimulation (iTBS)	0 of 41 (0%)	8 of 41 (19.5%)	0 of 41
Continuous Theta-burst Stimulation (cTBS)	0 of 37 (0%)	8 of 37 (21.6%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28249070Froeliger B, McConnell PA, Bell S, Sweitzer M, Kozink RV, Eichberg C, Hallyburton M, Kaiser N, Gray KM, McClernon FJ. Association Between Baseline Corticothalamic-Mediated Inhibitory Control and Smoking Relapse Vulnerability. JAMA Psychiatry. 2017 Apr 1;74(4):379-386. doi: 10.1001/jamapsychiatry.2017.0017.
Derived from this study: PubMed 37567363Upton S, Brown AA, Ithman M, Newman-Norlund R, Sahlem G, Prisciandaro JJ, McClure EA, Froeliger B. Effects of Hyperdirect Pathway Theta Burst Transcranial Magnetic Stimulation on Inhibitory Control, Craving, and Smoking in Adults With Nicotine Dependence: A Double-Blind, Randomized Crossover Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Nov;8(11):1156-1165. doi: 10.1016/j.bpsc.2023.07.014. Epub 2023 Aug 9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment. (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03960138, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.