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

NCT ID: NCT02534454

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-15

Study Completion Date

2018-03-31

Brief Summary

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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

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active TDCS + Active Retraining

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

Group Type EXPERIMENTAL

Active Retraining

Intervention Type BEHAVIORAL

Active transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Nicotine Replacement Therapy (Habitrol)

Intervention Type DRUG

Administration of Nicotine Replacement Therapy Patches

Sham TDCS + Active Retraining

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

Group Type EXPERIMENTAL

Active Retraining

Intervention Type BEHAVIORAL

Sham transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Nicotine Replacement Therapy (Habitrol)

Intervention Type DRUG

Administration of Nicotine Replacement Therapy Patches

Active TDCS + Sham retraining

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

Group Type EXPERIMENTAL

Sham Retraining

Intervention Type BEHAVIORAL

Active transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Nicotine Replacement Therapy (Habitrol)

Intervention Type DRUG

Administration of Nicotine Replacement Therapy Patches

Sham TDCS + Sham Retraining

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

Group Type EXPERIMENTAL

Sham Retraining

Intervention Type BEHAVIORAL

Sham transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Nicotine Replacement Therapy (Habitrol)

Intervention Type DRUG

Administration of Nicotine Replacement Therapy Patches

Interventions

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Active Retraining

Intervention Type BEHAVIORAL

Sham Retraining

Intervention Type BEHAVIORAL

Active transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Sham transcranial direct current stimulation (TDCS)

Intervention Type DEVICE

Nicotine Replacement Therapy (Habitrol)

Administration of Nicotine Replacement Therapy Patches

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Mind Research Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Mind Research Network

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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R21DA037546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20547

Identifier Type: -

Identifier Source: org_study_id

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