Clinical trial NCT02534454: TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
Official title: Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: The Mind Research Network
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-08-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cigarettes per Smoking Day
timeFrame: 11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining
Secondary outcomes:
measure: Approach Bias Towards Cigarettes (Measure of response time differences)
timeFrame: 1 week Post-transcranial direct current stimulation (TDCS)/Retraining
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network
state: New Mexico
Study officials:
References: