Nicotine DependencePhase 4NCT06798324
tDCS Plus Varenicline for Smoking Cessation
A Phase 4 study testing Active Transcranial Direct Current Stimulation (tDCS) and Varenicline 1mg BID in people with Nicotine Dependence and Tobacco Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine if active transcranial direct current stimulation (tDCS) plus varenicline is an effective, safe and accessible treatment option for smoking cessation. The main questions this trial aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS) and Varenicline 1mg BID
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 10 Mar 2025to 1 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to provide informed written consent
- Stated willingness to comply with all study procedures
- Age 18-85 years
- Smoke ≥ 8 cigarettes per day (CPD)
- Is seeking treatment for tobacco dependence
- Willing to attend the required clinic appointments (Two consecutive weeks, Monday through Friday)
- Otherwise healthy (i.e. not suffering from any major illness/condition that would impact their participation in the study)
Who cannot join
- Use of smoking cessation medication (e.g. buproprion, varenicline, NRT, cytisine) in the past 3 months
- Current regular use of nicotine-containing products besides cigarettes (e.g. electronic cigarettes, etc.)
- Unstable psychiatric illness that would adversely impact study participation and compliance (determined by the QI)
- History of seizures/epilepsy
- Lifetime history of concussions or head traumas
- Current pregnancy or plans to become pregnant
Show all 10Show fewer
- Current pacemakers or implanted electrical devices
- Current metal embedded in the skull
- Presence of skin lesions, open wounds, or bruising at stimulation sites; or
- Contraindications to varenicline use (e.g. pregnant/breastfeeding, alcohol dependence, kidney disease/renal impairment, known hypersensitivity to varenicline)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1P7
Laurie A Zawertailo, PhD, 416-535-8501 ext. 77422, laurie.zawertailo@camh.ca
Laurie Zawertailo, PhD
About this study
Official title: Using Non-Invasive Brain Stimulation (tDCS) as an Adjunct to Varenicline for the Treatment of Tobacco Dependence: a Randomized Controlled Trial
The goal of this clinical trial is to determine if active transcranial direct current stimulation (tDCS) plus varenicline is an effective, safe and accessible treatment option for smoking cessation. The main questions this trial aims to answer are:
- Does active tDCS plus varenicline improve short-term and long-term smoking abstinence rates compared to sham tDCS plus varenicline?
- Are the safety profiles between active tDCS plus varenicline and sham tDCS plus varenicline different?
The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment.
Read the detailed description
Smoking remains the leading cause of lung cancer globally, with cigarette smokers being about 20 times more likely to develop lung cancer than non-smokers. Despite the availability of effective treatments and extensive public health efforts, quitting smoking remains a significant challenge. Varenicline is currently the most effective medication for smoking cessation, yet most users relapse within the first year. No new medications for smoking cessation have come to market in the past two decades, and as such there is a critical need to optimize existing treatments. Combining treatment modalities can produce therapeutic synergism and improve overall treatment outcomes. Non-invasive brain stimulation techniques have become a popular area of research as a treatment option for substance use disorders with growing evidence of their effectiveness for a variety of addictions. One of these techniques, transcranial direct current stimulation (tDCS), has demonstrated potential in modulating the neuroadaptations associated with chronic smoking and relapse risk. A prior pilot study in our lab found that adjunct active tDCS doubled varenicline's effectiveness at end of treatment. Therefore, the objectives for this trial are as follows:
- To determine the short-term efficacy of active anodal tDCS to the left DLPFC plus varenicline compared to sham tDCS plus varenicline.
- To determine the effect of active anodal tDCS to the left DLPFC plus varenicline on sustained abstinence over time.
- To determine the safety of active anodal tDCS to the left DLPFC plus varenicline compared to sham tDCS plus varenicline.
This study will be a double-blind sham-controlled randomized clinical trial whereby 160 daily cigarette smokers will be recruited. After confirming eligibility at an assessment visit, participants will be randomized (1:1) to one of two groups: 1) Experimental group of active tDCS sessions plus 12 weeks of 1 mg varenicline bid (n=80); and 2) Control group of sham tDCS sessions plus 12 weeks of 1 mg varenicline bid (n=80). Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 in-person bi-weekly booster sessions for the remainder of the treatment period, and then 2 in-person follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. At the 1st daily session, participants will come in-person to be trained on using the tDCS device and provided with a study kit including all relevant study equipment. The following 8 daily sessions will occur remotely, and be monitored by research personnel over Webex. The 10th daily tDCS session will occur in-person, with participants returning the study kit. All 5 bi-weekly booster sessions will occur in-person. Total Study duration (with follow-up) is 12 months.
- Conditions
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Tobacco Use Disorder, Substance Use Disorders
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Varenicline 1mg BID, Sham Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Smoking, Tobacco Use Disorder, Smoking Cessation, Substance Use Disorders, Brain Stimulation, Transcranial Direct Current Stimulation, Tobacco Cigarettes, tDCS, Varenicline
- Medical subject headings
- Tobacco Use Disorder, Tobacco Smoking, Smoking Cessation, Substance-Related Disorders, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current Stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Active tDCS involves brief (e.g., 20-min) application of weak electric current (e.g., 2 mA) to the scalp. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT.
Varenicline 1mg BIDDrug
Also called Champix, Chantix
Varenicline is the most effective approved treatment for quitting smoking. Varenicline as per standard prescribing for dose escalation (i.e. Days 1 to 3: 0.5 mg once daily; Days 4 to 7: 0.5 mg twice daily; Days 8 to end of treatment: 1 mg twice daily) will be given concurrently over the same 2 weeks as the tDCS protocol and continue for an additional 10 weeks as per standard treatment duration recommended on the product monograph for a total of 12 weeks of varenicline treatment. Dose adjustments due to adverse events will be allowed (i.e. decrease to 0.5 mg twice daily).
The target quit date for smoking cessation will be on the last day of the two weeks of daily tDCS which corresponds to the recommended quit date after starting varenicline treatment.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Sham tDCS consists of 30s of 2 mA at the beginning and at the end of the 6 session (ramp up and down), then receiving 0 mA stimulation for the middle 19 min. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Active tDCS plus Varenicline) | Active comparator | The experimental group will receive active tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. Receives: Device: Active Transcranial Direct Current Stimulation (tDCS); Drug: Varenicline 1mg BID |
| Control Group | Sham comparator | The control group will receive sham (fake) tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. Receives: Drug: Varenicline 1mg BID; Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Continuous Abstinence at End-Of-Treatment
Proportion of the sample that has been abstinent from smoking for 30 days at end of treatment (treatment weeks 9-12), verified with a negative urinary cotinine test.
Measured: Week 9-12
Secondary outcomes (5)
Long-term Sustained Abstinence at Follow-Up
Continuous abstinence at 6-months (weeks 9 to 26) and 12-month (weeks 9 to 52) follow-up (verified with a negative urinary cotinine test).
Measured: Weeks 9-26 and Weeks 9-52
Adverse events
Adverse events will be recorded throughout the treatment and in follow-up visits.
Measured: Week 1-52
Working Memory Scores
The N-back Task will be used throughout the study to evaluate changes in working memory.
Measured: Week 1-52
Attentional Bias
Attentional bias towards smoking cues, sensation-seeking cues, and negative affect cues will be evaluated throughout the study using eye-tracking technology.
Measured: Week 1-52
Inhibitory Control Scores
Inhibitory control will be evaluated throughout the study using the Stop Signal Task and the Sustained Attention to Response Task.
Measured: Week 1-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start10 Mar 2025
- Primary completion20 Jan 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Laurie A Zawertailo, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798324
- Sponsor's protocol ID
- 081-2024
- Other IDs
- 508405
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Zawertailo L, Zhang H, Rahmani N, Rajji TK, Selby P. Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. PLoS One. 2022 Dec 8;17(12):e0277408. doi: 10.1371/journal.pone.0277408. eCollection 2022.
PubMed 36480510Zhang H, Rajji TK, Selby P, Melamed O, Attwells S, Zawertailo L. Augmenting varenicline treatment with transcranial direct current stimulation (tDCS) increases smoking abstinence rates at end of treatment. Brain Stimul. 2023 Jul-Aug;16(4):1083-1085. doi: 10.1016/j.brs.2023.07.001. Epub 2023 Jul 3. No abstract available.
PubMed 37406928
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Non-Invasive Brain Stimulation (tDCS) as an Adjunct to Varenicline for the Treatment of Tobacco Dependence: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06798324
- Acronym / sponsor ID
- 081-2024
- Conditions
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Tobacco Use Disorder, Substance Use Disorders
- Keywords
- Smoking, Tobacco Use Disorder, Smoking Cessation, Substance Use Disorders, Brain Stimulation, Transcranial Direct Current Stimulation, Tobacco Cigarettes, tDCS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine if active transcranial direct current stimulation (tDCS) plus varenicline is an effective, safe and accessible treatment option for smoking cessation. The main questions this trial aims to answer are:
- Does active tDCS plus varenicline improve short-term and long-term smoking abstinence rates compared to sham tDCS plus varenicline?
- Are the safety profiles between active tDCS plus varenicline and sham tDCS plus varenicline different?
The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment.
Detailed description
Smoking remains the leading cause of lung cancer globally, with cigarette smokers being about 20 times more likely to develop lung cancer than non-smokers. Despite the availability of effective treatments and extensive public health efforts, quitting smoking remains a significant challenge. Varenicline is currently the most effective medication for smoking cessation, yet most users relapse within the first year. No new medications for smoking cessation have come to market in the past two decades, and as such there is a critical need to optimize existing treatments. Combining treatment modalities can produce therapeutic synergism and improve overall treatment outcomes. Non-invasive brain stimulation techniques have become a popular area of research as a treatment option for substance use disorders with growing evidence of their effectiveness for a variety of addictions. One of these techniques, transcranial direct current stimulation (tDCS), has demonstrated potential in modulating the neuroadaptations associated with chronic smoking and relapse risk. A prior pilot study in our lab found that adjunct active tDCS doubled varenicline's effectiveness at end of treatment. Therefore, the objectives for this trial are as follows:
- To determine the short-term efficacy of active anodal tDCS to the left DLPFC plus varenicline compared to sham tDCS plus varenicline.
- To determine the effect of active anodal tDCS to the left DLPFC plus varenicline on sustained abstinence over time.
- To determine the safety of active anodal tDCS to the left DLPFC plus varenicline compared to sham tDCS plus varenicline.
This study will be a double-blind sham-controlled randomized clinical trial whereby 160 daily cigarette smokers will be recruited. After confirming eligibility at an assessment visit, participants will be randomized (1:1) to one of two groups: 1) Experimental group of active tDCS sessions plus 12 weeks of 1 mg varenicline bid (n=80); and 2) Control group of sham tDCS sessions plus 12 weeks of 1 mg varenicline bid (n=80). Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 in-person bi-weekly booster sessions for the remainder of the treatment period, and then 2 in-person follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. At the 1st daily session, participants will come in-person to be trained on using the tDCS device and provided with a study kit including all relevant study equipment. The following 8 daily sessions will occur remotely, and be monitored by research personnel over Webex. The 10th daily tDCS session will occur in-person, with participants returning the study kit. All 5 bi-weekly booster sessions will occur in-person. Total Study duration (with follow-up) is 12 months.
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 |
|---|---|---|
| Experimental Group (Active tDCS plus Varenicline) | Active comparator | Device: Active Transcranial Direct Current Stimulation (tDCS), Drug: Varenicline 1mg BIDThe experimental group will receive active tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. |
| Control Group | Sham comparator | Drug: Varenicline 1mg BID, Device: Sham Transcranial Direct Current Stimulation (tDCS)The control group will receive sham (fake) tDCS sessions plus 12 weeks of 1 mg varenicline bid. Participants will start varenicline treatment on the same day as the first tDCS session, and will follow a standard dose escalation schedule. The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to provide informed written consent
- Stated willingness to comply with all study procedures
- Age 18-85 years
- Smoke ≥ 8 cigarettes per day (CPD)
- Is seeking treatment for tobacco dependence
Key exclusion criteria (10 listed)
- Use of smoking cessation medication (e.g. buproprion, varenicline, NRT, cytisine) in the past 3 months
- Current regular use of nicotine-containing products besides cigarettes (e.g. electronic cigarettes, etc.)
- Unstable psychiatric illness that would adversely impact study participation and compliance (determined by the QI)
- History of seizures/epilepsy
- Lifetime history of concussions or head traumas
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 |
|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Active tDCS involves brief (e.g., 20-min) application of weak electric current (e.g., 2 mA) to the scalp. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT. | Device | Experimental Group (Active tDCS plus Varenicline) |
| Varenicline 1mg BIDAlso: Champix, ChantixVarenicline is the most effective approved treatment for quitting smoking. Varenicline as per standard prescribing for dose escalation (i.e. Days 1 to 3: 0.5 mg once daily; Days 4 to 7: 0.5 mg twice daily; Days 8 to end of treatment: 1 mg twice daily) will be given concurrently over the same 2 weeks as the tDCS protocol and continue for an additional 10 weeks as per standard treatment duration recommended on the product monograph for a total of 12 weeks of varenicline treatment. Dose adjustments due to adverse events will be allowed (i.e. decrease to 0.5 mg twice daily). The target quit date for smoking cessation will be on the last day of the two weeks of daily tDCS which corresponds to the recommended quit date after starting varenicline treatment. | Drug | Control Group, Experimental Group (Active tDCS plus Varenicline) |
| Sham Transcranial Direct Current Stimulation (tDCS)Sham tDCS consists of 30s of 2 mA at the beginning and at the end of the 6 session (ramp up and down), then receiving 0 mA stimulation for the middle 19 min. The tDCS device that will be used for this study is the Soterix 1x1 mini-CT. | Device | Control Group |
Primary outcome
30-Day Continuous Abstinence at End-Of-Treatment
Time frame: Week 9-12
Proportion of the sample that has been abstinent from smoking for 30 days at end of treatment (treatment weeks 9-12), verified with a negative urinary cotinine test.
5 secondary outcomes
Long-term Sustained Abstinence at Follow-Up
Time frame: Weeks 9-26 and Weeks 9-52
Adverse events
Time frame: Week 1-52
Working Memory Scores
Time frame: Week 1-52
Attentional Bias
Time frame: Week 1-52
Inhibitory Control Scores
Time frame: Week 1-52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 36480510Zawertailo L, Zhang H, Rahmani N, Rajji TK, Selby P. Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. PLoS One. 2022 Dec 8;17(12):e0277408. doi: 10.1371/journal.pone.0277408. eCollection 2022.
- Background: PubMed 37406928Zhang H, Rajji TK, Selby P, Melamed O, Attwells S, Zawertailo L. Augmenting varenicline treatment with transcranial direct current stimulation (tDCS) increases smoking abstinence rates at end of treatment. Brain Stimul. 2023 Jul-Aug;16(4):1083-1085. doi: 10.1016/j.brs.2023.07.001. Epub 2023 Jul 3. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Laurie A Zawertailo, PhD 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 Phase 4 study testing Active Transcranial Direct Current Stimulation (tDCS) and Varenicline 1mg BID in people with Nicotine Dependence and Tobacco Smoking, 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 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie A Zawertailo, PhD (416-535-8501 ext. 77422, laurie.zawertailo@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Continuous Abstinence at End-Of-Treatment (time frame: Week 9-12). 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 NCT06798324, 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 12 Aug 2025.