Clinical trial NCT01523730: Effects of rTMS on Cigarette Smoking and Cognition in Schizophrenia
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking and Cognitive Function in Smokers With and Without Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Nicotine Addiction
Keywords: Schizophrenia
Nicotine
Transcranial Magnetic Stimulation
Cognition
EEG
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-02-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cigarette smoking rates are extremely high in persons with schizophrenia and this increases the risk of disease and death due to tobacco-related disorders. One of the features of schizophrenia is reduced cognitive abilities, such as poor attention and memory. It is thought that people with schizophrenia smoke cigarettes to reduce these cognitive problems, as nicotine can improve cognitive function in these people. When people with schizophrenia stop smoking it causes further cognitive difficulties, which makes quitting harder for them compared to people without schizophrenia. A method called repetitive transcranial magnetic stimulation (rTMS) allows clinicians to give repeated magnetic pulses through the scalp to cause changes in brain activity and behaviour. rTMS can improve cognitive function in people with schizophrenia. Studies have also shown that rTMS can reduce tobacco craving and consumption of cigarettes. Therefore, we believe that rTMS will improve the cognitive deficits observed during cigarette smoking abstinence and help reduce cravings for cigarettes. Ultimately, rTMS may help smokers with schizophrenia who can't quit smoking with available treatments. This study will examine the effect of rTMS on tobacco cravings and cognitive problems produced by overnight abstinence from cigarette smoking in persons with schizophrenia in comparison to people without mental illness who smoke. Important information about the potential of rTMS for the treatment of cognitive deficits and tobacco addiction in schizophrenia will be obtained. Providing more effective smoking cessation treatments in people with schizophrenia may lead to improved physical and mental health for these patients, who are extremely susceptible to tobacco addiction and tobacco-related illness.


Eligibility criteria: Inclusion Criteria for all subjects:

1. Have a Full Scale IQ ≥ 80 as determined by the Shipley-2 which provides an estimate of pre-morbid intelligence
2. Be non-treatment seeking smokers;
3. Have a score greater than 5 on the Fagerstrom Test of Nicotine Dependence (FTND), a 5-item multiple choice questionnaire which assesses nicotine dependence
4. Report smoking of at least 10 cigarettes per day using a self-report 7-day timeline follow-back
5. Have an expired breath CO level \>10ppm
6. Be able to provide informed consent.

Inclusion Criteria for Schizophrenia Subjects:

1. Meet SCID for DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder
2. Be in stable remission from positive symptoms of psychosis as judged by psychiatric evaluation and a PANSS total score \<70
3. Be receiving a stable dose of antipsychotic mediation(s) for at least one month.

Inclusion Criteria for Healthy Controls:

1. Do not meet SCID for DSM-IV criteria for any current or past psychiatric disorder except for past major depression if it has been in remission for a minimum of one year
2. Not taking any psychotropic medications

General Exclusion Criteria:

1. Meet criteria for abuse or dependence of alcohol or illicit substances within the past 3 months (with the exception of nicotine dependence or caffeine)
2. Use of nicotine replacement or tobacco products other than cigarettes
3. Concomitant medical illness (including unstable or other presentations thought by investigators to compromise study participation, e.g. diabetes mellitus, hypothyroidism or acute/chronic renal insufficiency) or neurological illness including a history of seizures or a first-degree relative with a history of a seizure disorder
4. Be pregnant or planning to become pregnant
5. Metallic implants.

Primary outcomes:
measure: Cigarette craving as assessed by Tiffany Questionnaire for Smoking Urges (TQSU)
timeFrame: Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
Secondary outcomes:
measure: Cigarette withdrawal using the Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Expired breath carbon monoxide (CO) levels
timeFrame: Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 1 and 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Plasma nicotine/cotinine levels
timeFrame: Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Continuous Performance Test-X (CPT-X)
timeFrame: Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: N-back
timeFrame: Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Spatial Delayed Response (SDR)
timeFrame: Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: EEG recording during performance of N-back Task
timeFrame: Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Hopkins Verbal Learning Test Revised (HVLT-R)
timeFrame: Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
measure: Smoking Topography
timeFrame: Week 1 and 2: At baseline, day 2 when smoking as usual and following over-night smoking abstinence day 3
measure: Spontaneous smoking
timeFrame: Week 1 and 2: Pre- and post rTMS/sham treatment at baseline day 1 and 2 when smoking as usual) and following over-night smoking abstinence day 3
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, Schizophrenia Program, Toronto, ON, Canada
name: Tony P George, M.D.
role: PRINCIPAL_INVESTIGATOR
References: