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

The Mind Research Network

Status: Completed

Conditions: Nicotine Dependence

Treatments: Behavioral: Sham Retraining; Drug: Nicotine Replacement Therapy (Habitrol); Behavioral: Active Retraining; Device: Sham transcranial direct current stimulation (TDCS); Device: Active transcranial direct current stimulation (TDCS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02534454

20547

R21DA037546 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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86 participants in 4 patient groups

Active TDCS + Active Retraining

Experimental group

Description:

2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining

Treatment:

Drug: Nicotine Replacement Therapy (Habitrol)

Device: Active transcranial direct current stimulation (TDCS)

Behavioral: Active Retraining

Sham TDCS + Active Retraining

Experimental group

Description:

0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining

Treatment:

Drug: Nicotine Replacement Therapy (Habitrol)

Device: Sham transcranial direct current stimulation (TDCS)

Behavioral: Active Retraining

Active TDCS + Sham retraining

Experimental group

Description:

2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining

Treatment:

Behavioral: Sham Retraining

Drug: Nicotine Replacement Therapy (Habitrol)

Device: Active transcranial direct current stimulation (TDCS)

Sham TDCS + Sham Retraining

Experimental group

Description:

0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining

Treatment:

Behavioral: Sham Retraining

Drug: Nicotine Replacement Therapy (Habitrol)

Device: Sham transcranial direct current stimulation (TDCS)