Nicotine DependenceTDCSNICNCT02534454
TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
A study testing Active Retraining, Active transcranial direct current stimulation (TDCS) and Nicotine Replacement Therapy (Habitrol) in people with Nicotine Dependence, run by The Mind Research Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Active Retraining, Active transcranial direct current stimulation (TDCS) and Nicotine Replacement Therapy (Habitrol)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2015to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Official title: Transcranial Direct Current Stimulation (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.
- Conditions
- Nicotine Dependence
- Being tested
- Active Retraining, Sham Retraining, Active transcranial direct current stimulation (TDCS), Sham transcranial direct current stimulation (TDCS), Nicotine Replacement Therapy (Habitrol)
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RetrainingBehavioural
Sham RetrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Active TDCS + Active Retraining | Experimental | 2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining Receives: Behavioral: Active Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol) |
| Sham TDCS + Active Retraining | Experimental | 0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining Receives: Behavioral: Active Retraining; Device: Sham transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol) |
| Active TDCS + Sham retraining | Experimental | 2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining Receives: Behavioral: Sham Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol) |
| Sham TDCS + Sham Retraining | Experimental | 0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining Receives: Behavioral: Sham Retraining; Device: Sham transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining
Secondary outcomes (1)
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)
Measured: 1 week Post-transcranial direct current stimulation (TDCS)/Retraining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start15 Aug 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534454
- Sponsor's protocol ID
- 20547
- Other IDs
- R21DA037546
- Acronym
- TDCSNIC
- Status last verified
- May 2018
- First submitted
- 24 Aug 2015
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
- ClinicalTrials.gov ID
- NCT02534454
- Acronym / sponsor ID
- TDCSNIC / 20547
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active TDCS + Active Retraining | Experimental | Behavioral: Active Retraining, Device: Active transcranial direct current stimulation (TDCS), Drug: Nicotine Replacement Therapy (Habitrol)2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining |
| Sham TDCS + Active Retraining | Experimental | Behavioral: Active Retraining, Device: Sham transcranial direct current stimulation (TDCS), Drug: Nicotine Replacement Therapy (Habitrol)0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining |
| Active TDCS + Sham retraining | Experimental | Behavioral: Sham Retraining, Device: Active transcranial direct current stimulation (TDCS), Drug: Nicotine Replacement Therapy (Habitrol)2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining |
| Sham TDCS + Sham Retraining | Experimental | Behavioral: Sham Retraining, Device: Sham transcranial direct current stimulation (TDCS), Drug: Nicotine Replacement Therapy (Habitrol)0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Retraining | Behavioural | Active TDCS + Active Retraining, Sham TDCS + Active Retraining |
| Sham Retraining | Behavioural | Active TDCS + Sham retraining, Sham TDCS + Sham Retraining |
| Active transcranial direct current stimulation (TDCS) | Device | Active TDCS + Active Retraining, Active TDCS + Sham retraining |
| Sham transcranial direct current stimulation (TDCS) | Device | Sham TDCS + Active Retraining, Sham TDCS + Sham Retraining |
| Nicotine Replacement Therapy (Habitrol)Administration of Nicotine Replacement Therapy Patches | Drug | Active TDCS + Active Retraining, Active TDCS + Sham retraining, Sham TDCS + Active Retraining, Sham TDCS + Sham Retraining |
Primary outcome
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.
1 secondary outcome
Approach Bias Towards Cigarettes (Measure of response time differences)
Time frame: 1 week Post-transcranial direct current stimulation (TDCS)/Retraining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Retraining, Active transcranial direct current stimulation (TDCS) and Nicotine Replacement Therapy (Habitrol) in people with Nicotine Dependence, run by The Mind Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarettes per Smoking Day (time frame: 11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.