Tobacco Use DisorderNCT04083144
Deep rTMS and Varenicline for Smoking Cessation
A study testing Deep Repetitive Transcranial Magnetic Stimulation (Active) and Varenicline in people with Tobacco Use Disorder and Smoking Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Deep Repetitive Transcranial Magnetic Stimulation (Active) and Varenicline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2019to 30 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65;
- Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.
Who cannot join
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Allergy and/or contraindication to varenicline or rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
- Current or historical evidence of suicidal behavior;
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- Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
- Current, personal history or family history of seizures;
- Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score <24;
- Concomitant use of medication that lowers seizure threshold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
Read the detailed description
This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are:
- To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment.
- To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity.
- To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up.
Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Being tested
- Deep Repetitive Transcranial Magnetic Stimulation (Active), Deep Repetitive Transcranial Magnetic Stimulation (Sham), Varenicline
- Keywords
- smoking cessation, varenicline, deep rTMS, insula, addiction, tobacco use disorder
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Repetitive Transcranial Magnetic Stimulation (Active)Device
Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Deep Repetitive Transcranial Magnetic Stimulation (Sham)Device
Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.
VareniclineDrug
Also called Champix
12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).
| Study group | Role | What they receive |
|---|---|---|
| Deep rTMS active + Varenicline | Active comparator | Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. Receives: Device: Deep Repetitive Transcranial Magnetic Stimulation (Active); Drug: Varenicline |
| Deep rTMS sham + Varenicline | Sham comparator | Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. Receives: Device: Deep Repetitive Transcranial Magnetic Stimulation (Sham); Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Prevalence Abstinence at the End of 12 Weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Measured: 12 weeks
Secondary outcomes (9)
Fagerstrom Test For Nicotine Dependence (FTND) Score
This will be used to assess physical dependence severity in participants. It is a 6 item scale and total scores can range from 0-10. A higher score indicates more severe nicotine dependence.
Measured: 26 weeks
Expired CO Measurements
This will be used as a biological confirmation of recent smoking.
Measured: 26 weeks
Cigarettes Per Day (TLFB)
Self-reported measure of cigarette consumption.
Measured: 26 weeks
Minnesota Nicotine Withdrawal Scale (MNWS) Score
This will be used to assess withdrawal symptoms. It is an 8 item scale and total scores range from 0 to 24. A higher score indicates more severe nicotine withdrawal.
Measured: 26 weeks
Tiffany Questionnaire for Smoking Urges (T-QSU) Score
This will be used to assess symptoms of craving/urges for tobacco. It is a 32 item scale and total scores range from 0 to 224. A higher score indicates more severe smoking craving/urges.
Measured: 26 weeks
Point Prevalence Abstinence at the End of 4 Weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Measured: 4 weeks
Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26)
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Measured: 26 weeks
Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26)
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Measured: 26 weeks
Continuous Abstinence at 6 Months
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start22 Aug 2019
- Primary completion13 Sep 2022
- Study completion30 Dec 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Brainsway
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD,PhD,MCFP, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083144
- Sponsor's protocol ID
- 051/2017
- Status last verified
- Aug 2024
- First submitted
- 6 Sep 2019
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibrahim C, Malik S, Barr MS, Blumberger DM, Daskalakis ZJ, Le Foll B. Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol. Front Pharmacol. 2022 Sep 8;13:969500. doi: 10.3389/fphar.2022.969500. eCollection 2022.
PubMed 36160428
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
- ClinicalTrials.gov ID
- NCT04083144
- Acronym / sponsor ID
- 051/2017
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Keywords
- smoking cessation, varenicline, deep rTMS, insula, addiction, tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Pfizer, Brainsway
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 4 Nov 2024
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 study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
Detailed description
This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are:
- To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment.
- To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity.
- To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up.
Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep rTMS active + Varenicline | Active comparator | Device: Deep Repetitive Transcranial Magnetic Stimulation (Active), Drug: VareniclineParticipants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. |
| Deep rTMS sham + Varenicline | Sham comparator | Device: Deep Repetitive Transcranial Magnetic Stimulation (Sham), Drug: VareniclineParticipants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65;
- Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.
Key exclusion criteria (10 listed)
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Allergy and/or contraindication to varenicline or rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
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 |
|---|---|---|
| Deep Repetitive Transcranial Magnetic Stimulation (Active)Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula | Device | Deep rTMS active + Varenicline |
| Deep Repetitive Transcranial Magnetic Stimulation (Sham)Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations. | Device | Deep rTMS sham + Varenicline |
| VareniclineAlso: Champix12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day). | Drug | Deep rTMS active + Varenicline, Deep rTMS sham + Varenicline |
Primary outcome
Point Prevalence Abstinence at the End of 12 Weeks
Time frame: 12 weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
9 secondary outcomes
Fagerstrom Test For Nicotine Dependence (FTND) Score
Time frame: 26 weeks
Expired CO Measurements
Time frame: 26 weeks
Cigarettes Per Day (TLFB)
Time frame: 26 weeks
Minnesota Nicotine Withdrawal Scale (MNWS) Score
Time frame: 26 weeks
Tiffany Questionnaire for Smoking Urges (T-QSU) Score
Time frame: 26 weeks
Point Prevalence Abstinence at the End of 4 Weeks
Time frame: 4 weeks
Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26)
Time frame: 26 weeks
Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26)
Time frame: 26 weeks
Continuous Abstinence at 6 Months
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36160428Ibrahim C, Malik S, Barr MS, Blumberger DM, Daskalakis ZJ, Le Foll B. Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol. Front Pharmacol. 2022 Sep 8;13:969500. doi: 10.3389/fphar.2022.969500. eCollection 2022.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teachingLink provided by the sponsor.
- 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.
Bernard Le Foll, MD,PhD,MCFP principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Repetitive Transcranial Magnetic Stimulation (Active) and Varenicline in people with Tobacco Use Disorder and Smoking Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 10 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 4 Nov 2024. 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 Canada. 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. Some participants in this study may receive a placebo. 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 4 Nov 2024). 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?
Point Prevalence Abstinence at the End of 12 Weeks (time frame: 12 weeks). 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 NCT04083144, which also lists 1 linked publication.
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 4 Nov 2024.