Clinical Trials Logo

Clinical Trial Summary

Tobacco smokers with schizophrenia are known to be resistant smokers, with high rates of smoking and inability to quit in the long-term, often related to smoking relapse. This may relate to problems with frontal lobe function associated with schizophrenia, which make these patients have great difficulty in dealing with smoking withdrawal, urges and cravings. The current study will develop a combination approach that takes advantage of brain stimulation of the frontal lobes (repetitive transcranial magnetic stimulation (rTMS), in combination with the anti-smoking drug varenicline, to prevent smoking lapse using a well-established human laboratory method. Results from this study may have important implications for developing novel treatment approaches for smokers with schizophrenia.

Clinical Trial Description

Tobacco smokers with schizophrenia (SWS) represent a subset of smokers with high smoking prevalence compared to the general population, and reduced ability to quit smoking and to resist smoking relapse. There is some evidence that first-line treatments for tobacco use disorder are safe and effective for smoking cessation and smoking relapse-prevention in SWS, but these treatments do not appear to be as effective in smokers with a mental illness as compared to non-psychiatric tobacco smokers. Novel approaches to identify safe and effective treatments using human laboratory models may be an efficient strategy towards this important clinical goal.

The proposed human laboratory study will test the effects of standard pharmacotherapy for tobacco use disorder, the nicotinic partial agonist varenicline, in combination with an established brain stimulation method (repetitive transcranial magnetic stimulation;Íž rTMS) in SWS. This will allow for the determination of the benefits of combining rTMS with varenciline in SWS using a validated smoking lapse paradigm developed by the collaborator Sherry McKee, Ph.D. at Yale University. The present study represents a novel neuroscience-based strategy for targeting dorsolateral prefrontal cortex (DLPFC) dysfunction in schizophrenia, and is consistent with a target engagement and validation approach as endorsed by NIDA/NIH. Moreover, the subject population the investigators are targeting (SWS) are prone to quit attempt failures and rapid relapse to tobacco smoking, and are in need of novel and effective anti-smoking lapse interventions. The investigators' preliminary data support the use of the combination of varenicline and high-frequency (20 Hz) rTMS to target smoking lapse and craving outcomes in SWS. Accordingly, the investigators believe that the proposed goals, approach and implications for treatment development are substantial and likely to impact positively on clinical treatment research outcomes in this marginalized population of tobacco smokers. Specifically, using a randomized, double-blind, placebo-controlled parallel groups experimental design, the investigators will determine whether the combination of varenicline (2 mg/day) and high-frequency (20 Hz) rTMS versus varenicline and sham rTMS directed to the DLPFC will be superior for the prevention of tobacco smoking lapse behaviors in cigarette smokers with schizophrenia (N=80).

Hypothesis 1 (H1): Active (20 Hz) versus Sham rTMS will increase the time to smoking lapse in combination with varenicline in SWS.

Hypothesis 2 (H2): Active (20 Hz) versus Sham rTMS will improve prefrontal cognition in SWS, and this will be associated with increased ability to resist smoking lapse. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03497299
Study type Interventional
Source Centre for Addiction and Mental Health
Contact Tony George, MD
Phone 416-535-8501
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2018
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Recruiting NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Recruiting NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Completed NCT01412060 - A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia Phase 3
Completed NCT01222793 - Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia N/A
Enrolling by invitation NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Recruiting NCT02868879 - Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Completed NCT01878513 - Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis N/A
Recruiting NCT03163706 - Evaluation of Stroop Effect in Patients With Schizophrenia N/A
Completed NCT00001921 - Electrophysiology and Blood Flow in Patients With Schizophrenia and Their Siblings
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02864576 - Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment N/A
Recruiting NCT02782442 - "Cognitive Training Delivered Remotely to Individuals With Psychosis N/A
Recruiting NCT02823041 - Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode N/A
Recruiting NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4