Clinical trial NCT00736710: rTMS Effects on Smoking Cessation and Cognition in Schizophrenia
Official title: Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Schizophrenia
Keywords: Repetitive Transcranial Magnetic Stimulation
Cigarette smoking
Schizophrenia
Randomized
Double-blind
Placebo-controlled
longitudinal
nicotine patch
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: trial endpoint
Secondary outcomes:
measure: P50/NI, N-Back and VSWM Working Memory Performance
timeFrame: intermittent
measure: Expired Breath Carbon Monoxide Levels
timeFrame: intermittent
measure: Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)
timeFrame: intemittent
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Tony George, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.