Nicotine Dependence
Conditions
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.
Interventions
BEHAVIORALActive Retraining
BEHAVIORALSham Retraining
DEVICEActive transcranial direct current stimulation (TDCS)
DEVICESham transcranial direct current stimulation (TDCS)
DRUGNicotine Replacement Therapy (Habitrol)
Administration of Nicotine Replacement Therapy Patches
Sponsors
National Institute on Drug Abuse (NIDA)
The Mind Research Network
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes per Smoking Day | 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
| Measure | Time frame | Description |
|---|---|---|
| Approach Bias Towards Cigarettes (Measure of response time differences) | 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) |
Countries
United States
Outcome results
None listed