Cigarette SmokingNCT00736710
rTMS Effects on Smoking Cessation and Cognition in Schizophrenia
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cigarette Smoking and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cigarette Smoking, Schizophrenia
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Smoking at least 10 cigarettes per day and a Fagerstrom score of at least 4.
- Willing to quit smoking in the next 30 days.
Who cannot join
- Active alcohol or illicit drug abuse or dependence in the past 3 months
- A history of seizures, head trauma or space occupying lesions.
- A history of alcohol or illicit drug abuse in the past 6 months.
- Intolerance of the nicotine patch or its excipients
- Evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation.
- Females who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch
Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. This study will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.
- Conditions
- Cigarette Smoking, Schizophrenia
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Cigarette smoking, Schizophrenia, Randomized, Double-blind, Placebo-controlled, longitudinal, nicotine patch
- Medical subject headings
- Cigarette Smoking, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.
Sham Repetitive Transcranial Magnetic Stimulation (rTMS)Procedure or surgery
The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| 2 | Sham comparator | Not described Receives: Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm.
Measured: trial endpoint
Secondary outcomes (3)
P50/NI, N-Back and VSWM Working Memory Performance
Measured: intermittent
Expired Breath Carbon Monoxide Levels
Measured: intermittent
Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)
Measured: intemittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony George, Centre for Addiction and Mental Health
- Investigators
- Tony George, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736710
- Sponsor's protocol ID
- 121/2007
- Status last verified
- Dec 2012
- First submitted
- 15 Aug 2008
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
PubMed 29486960
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch
- ClinicalTrials.gov ID
- NCT00736710
- Acronym / sponsor ID
- 121/2007
- Conditions
- Cigarette Smoking, Schizophrenia
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Cigarette smoking, Schizophrenia, Randomized, Double-blind, Placebo-controlled, longitudinal, nicotine patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Aug 2008 (estimated)
- 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.
Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. This study will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.
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 |
|---|---|---|
| 1 | Experimental | Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| 2 | Sham comparator | Procedure: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Smoking at least 10 cigarettes per day and a Fagerstrom score of at least 4.
- Willing to quit smoking in the next 30 days.
Key exclusion criteria (6 listed)
- Active alcohol or illicit drug abuse or dependence in the past 3 months
- A history of seizures, head trauma or space occupying lesions.
- A history of alcohol or illicit drug abuse in the past 6 months.
- Intolerance of the nicotine patch or its excipients
- Evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued. | Procedure or surgery | 1 |
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS)The rTMS procedures will be delivered in a single-blind fashion by the rTMS technician at the CAMH rTMS Laboratory. All subjects would be enrolled in a 10-week smoking cessation program using weekly group behavioral therapy which will emphasize psychoeducation about the effects of smoking on psychiatric and medical aspects of schizophrenia, social skills training, relapse-prevention skills training and benefits of quitting smoking. All subjects would start group therapy interventions in Week 1 of the trial, and begin rTMS procedures in a separate session on Week 2. The transdermal nicotine patch (TNP; 21 mg/24h) would be applied during the quit date at Week 3 (Day 15). At the end of the 10-week trial, TNP and group therapy would be discontinued. | Procedure or surgery | 2 |
Primary outcome
Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm.
Time frame: trial endpoint
3 secondary outcomes
P50/NI, N-Back and VSWM Working Memory Performance
Time frame: intermittent
Expired Breath Carbon Monoxide Levels
Time frame: intermittent
Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)
Time frame: intemittent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Derived from this study: PubMed 29486960Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Tony George, MD 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 Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cigarette Smoking and Schizophrenia, 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 3 inclusion and 6 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 5 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm. (time frame: trial endpoint). 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 NCT00736710, 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 5 Dec 2012.