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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Retraining
Sham Retraining
Active transcranial direct current stimulation (TDCS)
Sham transcranial direct current stimulation (TDCS)
Nicotine Replacement Therapy (Habitrol)
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • The Mind Research Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Active TDCS + Active Retraining

Sham TDCS + Active Retraining

Active TDCS + Sham retraining

Sham TDCS + Sham Retraining

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
August 24, 2015
Last Updated
May 16, 2018
Sponsor
The Mind Research Network
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02534454
Brief Title
TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
Acronym
TDCSNIC
Official Title
Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2015 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mind Research Network
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TDCS + Active Retraining
Arm Type
Experimental
Arm Description
2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Arm Title
Sham TDCS + Active Retraining
Arm Type
Experimental
Arm Description
0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
Arm Title
Active TDCS + Sham retraining
Arm Type
Experimental
Arm Description
2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Arm Title
Sham TDCS + Sham Retraining
Arm Type
Experimental
Arm Description
0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
Intervention Type
Behavioral
Intervention Name(s)
Active Retraining
Intervention Type
Behavioral
Intervention Name(s)
Sham Retraining
Intervention Type
Device
Intervention Name(s)
Active transcranial direct current stimulation (TDCS)
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation (TDCS)
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy (Habitrol)
Intervention Description
Administration of Nicotine Replacement Therapy Patches
Primary Outcome Measure Information:
Title
Cigarettes per Smoking Day
Description
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 Outcome Measure Information:
Title
Approach Bias Towards Cigarettes (Measure of response time differences)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

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

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