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

Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

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 Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Active Retraining; Behavioral: Sham Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol); Device: Sham transcranial direct current stimulation (TDCS)

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The Mind Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TDCS + Active Retraining; 2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining	Behavioral: Active Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol); Administration of Nicotine Replacement Therapy Patches
Experimental: Sham TDCS + Active Retraining; 0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining	Behavioral: Active Retraining; Drug: Nicotine Replacement Therapy (Habitrol); Administration of Nicotine Replacement Therapy Patches; Device: Sham transcranial direct current stimulation (TDCS)
Experimental: Active TDCS + Sham retraining; 2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining	Behavioral: Sham Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol); Administration of Nicotine Replacement Therapy Patches
Experimental: Sham TDCS + Sham Retraining; 0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining	Behavioral: Sham Retraining; Drug: Nicotine Replacement Therapy (Habitrol); Administration of Nicotine Replacement Therapy Patches; Device: Sham transcranial direct current stimulation (TDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 week Post-transcranial direct current stimulation (TDCS)/Retraining

Collaborators and Investigators

• Sponsor: The Mind Research Network
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2015
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20547; R21DA037546 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No