TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Behavioral: Active Retraining; Behavioral: Sham Retraining; Device: Active transcranial direct current stimulation (TDCS); Device: Sham transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol)

• Registration Number: NCT02534454
• Lead Sponsor: The Mind Research Network

Brief Summary

The purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (TDCS) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The recent use of TDCS over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. Previous studies of cognitive retraining have focused on implicit training techniques. This proposed study will attempt to enhance these implicit training techniques through the use of TDCS during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. The objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-15
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Consume 10 or more cigarettes/day average for the past 60 days
• Able to provide informed consent
• Less than 3 months smoking abstinence in the past year
• Right Handed

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Exclusion Criteria

• Serious medical illness within 6 months (e.g. cancer, hepatic, or renal disease)
• Significant cardiovascular disease (e.g. recent stroke or heart attack, arrhythmias, worsening angina pectoris, uncontrolled hypertension) generalized skin disorders, or sensitivity to the nicotine patch
• Use of illicit drugs (excluding marijuana) in the previous 30 days
• Psychosis, psychotic disorder, or bipolar disorder
• Current active major depression (depressive episode within last month)
• Clinically significant suicidal ideation
• Prior seizure
• Current bupropion or tricyclic antidepressants
• Current pregnancy, trying to become pregnant, or breastfeeding
• Current active alcohol dependence (symptoms in last 30 days)
• Left-handedness
• Current medication known to interact with nicotine replacement therapy (NRT) or smoking cessation (e.g. adenosine, cimetidine, conivaptan, cyproterone, peginterferon alfa-2bg, tocilizumab, theophylline)
• Metal in the head
• Implanted brain medical devices
• Electromedical devices
• Latex Allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Active TDCS + Active Retraining	Active transcranial direct current stimulation (TDCS)	2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Active TDCS + Active Retraining	Nicotine Replacement Therapy (Habitrol)	2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Sham TDCS + Active Retraining	Active Retraining	0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Sham TDCS + Active Retraining	Sham transcranial direct current stimulation (TDCS)	0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Active TDCS + Active Retraining	Active Retraining	2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Active TDCS + Sham retraining	Sham Retraining	2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Active TDCS + Sham retraining	Nicotine Replacement Therapy (Habitrol)	2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Sham TDCS + Sham Retraining	Sham transcranial direct current stimulation (TDCS)	0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Sham TDCS + Active Retraining	Nicotine Replacement Therapy (Habitrol)	0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Active TDCS + Sham retraining	Active transcranial direct current stimulation (TDCS)	2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Sham TDCS + Sham Retraining	Sham Retraining	0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Sham TDCS + Sham Retraining	Nicotine Replacement Therapy (Habitrol)	0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining

Primary Outcome Measures

Name	Time	Method
Cigarettes per Smoking Day	11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining	Number of cigarettes consumed per day will be assessed using the Timeline Follow-back method to obtain the number of cigarettes consumed on each day since the last administration of the Timeline Follow-back. Cigarettes per smoking day will be the mean number of cigarettes consumed on days on which cigarettes were consumed.

Secondary Outcome Measures

Name	Time	Method
Approach Bias Towards Cigarettes (Measure of response time differences)	1 week Post-transcranial direct current stimulation (TDCS)/Retraining	Measure of response time differences to push vs. pull a joystick in response to pictures of cigarettes vs. control objects (e.g. pens)

Trial Locations

Locations (1)

The Mind Research Network; 🇺🇸 Albuquerque, New Mexico, United States