Trial record 4 of 24 for:
Porencephaly
Transcranial Direct Current Stimulation in a Smoking Cessation Trial (tDCS)
This study is currently recruiting participants.
Verified April 2013 by Centre for Addiction and Mental Health
Sponsor:
Centre for Addiction and Mental Health
Collaborators:
Ontario Brain Institute
NorDocs Technologies, Inc. (regulatory sponsor with Health Canada)
Information provided by (Responsible Party):
Martin Zack, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01710410
First received: September 21, 2012
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is an effective add-on treatment in a validated smoking cessation protocol for nicotine dependent smokers.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence |
Device: SmartStim Model 200 tDCS Device |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment in a Validated Smoking Cessation Protocol for Nicotine Dependent Smokers |
Resource links provided by NLM:
Further study details as provided by Centre for Addiction and Mental Health:
Primary Outcome Measures:
- Smoking Cessation [ Time Frame: Participants will be followed for the duration of the study, an expected average of one year. ] [ Designated as safety issue: No ]Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure when combined with cognitive-behavioural group therapy plus nicotine patch.
Secondary Outcome Measures:
- Smoking cessation rate following transcranial direct current stimulation applied to the dorsolateral prefrontal cortex or orbitofrontal cortex. [ Time Frame: Participants will be followed for the duration of the study, an expected average of one year. ] [ Designated as safety issue: No ]Measure whether the benefits of active tDCS to the OFC (anode-left/cathode-right) is greater than the conventional configuration (anode-left/cathode-right) to the DLPFC.
Other Outcome Measures:
- Smoking cessation rate following transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex and orbitofrontal cortex versus the right dorsolateral prefrontal cortex and orbitofrontal cortex. [ Time Frame: Participants will be followed for the duration of the study, an expected average of one year. ] [ Designated as safety issue: No ]Measure whether the benefits of active tDCS (anode-left/cathode-right) to the OFC and to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to the respective regions.
| Estimated Enrollment: | 66 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DLPFC tDCS (left anode/right cathode)
Active transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
|
|
Experimental: DLPFC tDCS (left cathode/right anode)
Active transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
|
|
Experimental: OFC tDCS (left anode/right cathode)
Active transcranial Direct Current Stimulation (tDCS) administered to the left OFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
|
|
Experimental: OFC tDCS (left cathode/right anode)
Active transcranial Direct Current Stimulation (tDCS) administered to the right OFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
|
|
Sham Comparator: DLPFC tDCS
Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
|
|
Sham Comparator: OFC tDCS
Sham transcranial Direct Current Stimulation (tDCS) delivered to the OFC.
|
Device: SmartStim Model 200 tDCS Device
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
|
Detailed Description:
BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs.
OBJECTIVE: To assess whether tDCS delivered in addition to standard smoking cessation treatment (cognitive behavioural therapy and nicotine patch) reliably increases quit rates.
METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC) in both cerebral hemispheres.
HYPOTHESES:
- Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure when combined with cognitive-behavioural group therapy plus nicotine patch.
- The benefits of active tDCS to the OFC (anode-left/cathode-right) will be greater than the (anode-left/cathode-right)DLPFC configuration.
- The benefits of active tDCS (anode-left/cathode-right) to the OFC and to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to the respective regions.
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- nicotine dependent
- treatment-seeking
- smoke minimum of 15 cigarettes per day
- able to provide written informed consent
- able and willing to attend weekly appointments, inter-treatment and follow-up assessment
- able and willing to wear nicotine patch
Exclusion Criteria:
- currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics
- pregnancy or lactation
- any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy
- brain/neurological injury/disease/disorder
- skin disease
- current DSM-IV Axis I psychiatric disorder
- metal or medical device implants
- current treatment for alcohol or drug use
- current use of herbal/holistic preparations
- current use of recreational drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01710410
Contacts
| Contact: Romina D Coppa-Hopman, Ph.D. | 416.535.8501 ext 7295 | romina.coppa-hopman@camh.ca |
| Contact: Laurie Zawertailo, Ph.D. | 416.535.8501 ext 7422 | laurie.zawertailo@camh.ca |
Locations
| Canada, Ontario | |
| Centre for Addiction and Mental Health (Nicotine Dependence Clinic) | Recruiting |
| Toronto, Ontario, Canada, M5T 1P5 | |
| Contact: Romina D Coppa-Hopman, Ph.D. 416.535.8501 ext 7295 romina.coppa-hopman@camh.ca | |
| Contact: Laurie Zawertailo, Ph.D. 416.535.8501 ext 7422 laurie.zawertailo@camh.ca | |
| Principal Investigator: Martin Zack, Ph.D. | |
| Sub-Investigator: Peter Selby, MBBS | |
| Sub-Investigator: Laurie Zawertailo, Ph.D. | |
| Sub-Investigator: Jeff Daskalakis, M.D., Ph.D. | |
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Brain Institute
NorDocs Technologies, Inc. (regulatory sponsor with Health Canada)
Investigators
| Principal Investigator: | Martin Zack, Ph.D. | Centre for Addiction and Mental Health |
More Information
Additional Information:
Publications:
| Responsible Party: | Martin Zack, Principal Investigator, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01710410 History of Changes |
| Other Study ID Numbers: | #006/2012-01 |
| Study First Received: | September 21, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
transcranial Direct Current Stimulation nicotine dependence dorsolateral prefrontal cortex orbitofrontal cortex cognitive behavioural therapy |
nicotine replacement therapy nicotine patch addiction smoking cessation neuroplasticity |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Substance-Related Disorders Mental Disorders Habits Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013