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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Brainsway | INDUSTRY |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep rTMS active + Varenicline | Active Comparator | Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. |
|
| Deep rTMS sham + Varenicline | Sham Comparator | Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Repetitive Transcranial Magnetic Stimulation (Active) | Device | Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26 weeks |
| Expired CO Measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll, MD,PhD,MCFP | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36160428 | Derived | 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. |
| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching | View source |
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50 participants were enrolled, however, 8 of them were lost to follow up before randomization and therefore were not assigned to any group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep rTMS Active + Varenicline | Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula Varenicline: 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). |
| FG001 | Deep rTMS Sham + Varenicline | Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of 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. Varenicline: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep rTMS Active + Varenicline | Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula Varenicline: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep rTMS Active + Varenicline | Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline. Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula Varenicline: 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernard Le Foll | Centre for Addiction and Mental Health | 4165358501 | 33111 | bernard.lefoll@camh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2022 | Aug 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| Varenicline | Drug | 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). |
|
|
This will be used as a biological confirmation of recent smoking. |
| 26 weeks |
| Cigarettes Per Day (TLFB) | Self-reported measure of cigarette consumption. | 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. | 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. | 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. | 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. | 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. | 26 weeks |
| Continuous Abstinence at 6 Months | Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement. | 26 weeks |
| BG001 | Deep rTMS Sham + Varenicline | Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of 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. Varenicline: 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Education Years | Mean | Standard Deviation | years |
|
| Employment Status | Count of Participants | Participants |
|
| Housing | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Fagerström Test for Nicotine Dependence | Higher score = higher nicotine dependence severity Score 0-10 | Mean | Standard Deviation | Score out of 10 |
|
| Mini-mental state examination | Lower score = cognitive impairment Score 0-30 | Mean | Standard Deviation | Score out of 30 |
|
| Smoking Contemplation Ladder | Mean | Standard Deviation | Score out of 10 |
|
| CO Measurement | Mean | Standard Deviation | ppm |
|
| Cigarettes/day | The number of cigarettes smoked per day over the past 30 days | Mean | Standard Deviation | Cigarettes/day |
|
| Alcoholic Drinks/day | The number of alcoholic drinks consumed per day over the past 30 days | Mean | Standard Deviation | Drinks/day |
|
| Nicotine Metabolite Ratio | The ratio of 3'hydroxycotinine [3HC]/cotinine A low ratio indicates slow nicotine metabolism and a high ratio indicates fast nicotine metabolism. There is no clear cutoff of slow vs. fast metabolizer as it depends on the population studied and the methods used. | Mean | Standard Deviation | Ratio 0-1 |
|
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of 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. Varenicline: 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). |
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 26 weeks |
|
|
|
|
| Secondary | Expired CO Measurements | This will be used as a biological confirmation of recent smoking. | Posted | Mean | Standard Error | ppm | 26 weeks |
|
|
|
|
| Secondary | Cigarettes Per Day (TLFB) | Self-reported measure of cigarette consumption. | Posted | Mean | Standard Error | cigarettes/day | 26 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 26 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 26 weeks |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | Continuous Abstinence at 6 Months | Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 15 |
| 24 |
| EG001 | Deep rTMS Sham + Varenicline | Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of 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. Varenicline: 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). | 0 | 18 | 0 | 18 | 11 | 18 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Vivid Dreams | Product Issues | Systematic Assessment |
|
| Sleep Disturbances | Product Issues | Systematic Assessment |
|
| Diarrhea | Product Issues | Systematic Assessment |
|
| Fatigue | Product Issues | Systematic Assessment |
|
| Contispation/bloating | Product Issues | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Low Mood | Psychiatric disorders | Systematic Assessment |
|
| Dizzy | Nervous system disorders | Systematic Assessment |
|
| Leg pain/leg cramp | General disorders | Systematic Assessment |
|
| Nightmare | Product Issues | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Runny Nose | General disorders | Systematic Assessment |
|
| Trouble Concentrating | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Joint Stiffness | General disorders | Systematic Assessment |
|
| Muscle Cramp | General disorders | Systematic Assessment |
|
| Phosphene | General disorders | Systematic Assessment |
|
| Face twitching | General disorders | Systematic Assessment |
|
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Amoeba | General disorders | Systematic Assessment |
|
| Poor Memory | General disorders | Systematic Assessment |
|
| Dry Skin | General disorders | Systematic Assessment |
|
| Fentanyl Overdose | General disorders | Systematic Assessment |
|
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| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D011810 | Quinoxalines |