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Completed

NCT Number: NCT02534454

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.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Retraining

Behavioral

Sham Retraining

Behavioral

Active Transcranial Direct Current Stimulation (tDCS)

Device

Sham Transcranial Direct Current Stimulation (tDCS)

Device

Nicotine Replacement Therapy (Habitrol)

Drug

Administration of Nicotine Replacement Therapy Patches

Primary outcomes

  1. Cigarettes per Smoking Day

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

    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 outcomes

  1. Approach Bias Towards Cigarettes (Measure of response time differences)

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

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

Sponsors and collaborators

Lead sponsor

The Mind Research Network

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: TDCSNIC

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2015
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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