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

The Mind Research Network86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nicotine Dependence

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Cigarettes per Smoking Day

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.

Time frame: 11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining

Secondary Outcomes

Approach Bias Towards Cigarettes (Measure of response time differences)

Measure of response time differences to push vs. pull a joystick in response to pictures of cigarettes vs. control objects (e.g. pens)

Time frame: 1 week Post-transcranial direct current stimulation (TDCS)/Retraining