Nicotine DependenceNCT01782599
Electronic Cigarettes and Reactivity to Smoking Cues
A study testing Dual nicotine patch and electronic cigarette in people with Nicotine Dependence, run by Mclean Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Dual nicotine patch and electronic cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 24 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent.
- Be aged 18-45.
- Report smoking cigarettes daily in the past 6 months.
- Have expired breath CO indicative of regular smoking.
- Have a score greater than 0 on the FTND.
- Be willing to use Nicotine Replacement Therapy (NRT) and the e-cigarette for a period of 2 to 3 weeks.
- Speak and read English.
- Pass an MRI safety screen and meet inclusion criteria for MRI scans.
Who cannot join
- Be pregnant (measured via urinalysis).
- Meet current abuse or dependence criteria for any substance other than nicotine or caffeine (measured via the SCID 5).
- Produce a positive urine screen for drugs of abuse or alcohol at the fMRI scan visits.
- Meet DSM-IV criteria for major depressive episode in the past six months, lifetime DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder or psychotic disorders not elsewhere classified (measured via the SCID 5).
- Be currently suicidal as assessed by DSM 5 and the Beck Depression Inventory.
- Current use of medications or any history of a medical condition that might affect the central nervous system at the time of scanning including: Abnormal structural MRI, or a history of head trauma or injury causing loss of consciousness lasting longer than 3 minutes or associated with skull fracture or intracranial bleeding or who had irremovable magnetically active objects on or within their body, history of epilepsy, current use of a beta-blocker or prescription analgesic/anxiolytic. (assessed by self-report).
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- MRI exclusion criteria. (additional information outlined in the "protection of human subjects" section).
- History of claustrophobia.
- History of propylene glycol sensitivity/allergy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mclean Hospital Imaging Center
Belmont, Massachusetts, 02478
About this study
The purpose of this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues.
Read the detailed description
Tobacco-related illness causes over 5 million deaths per year in the developed world, and most currently available smoking cessation treatments do not effectively enhance long-term cessation outcomes. Reactivity to smoking cues is one factor associated with relapse vulnerability, which is untreated by cessation aids such as NRT. Combining treatments, which ameliorate both pharmacological nicotine withdrawal and reduce smoking cue reactivity, may enhance smoking cessation success. During this study we will test whether combining NRT with non-nicotine containing electronic cigarettes (e-cigarettes) effectively reduces reactivity to smoking cues. The only source of nicotine participants will receive during the study will come from NRT. We will use e-cigarettes that provide no nicotine, yet may provide a similar experience to smoking as e-cigarettes taste and feel similar to a regular cigarette. However, since nicotine delivery is not associated with the act of smoking the reinforcing effects associated with smoking behavior may be reduced. Reactivity to smoking cues will be assessed using a battery of measures including: self-report, behavioral, and neuroimaging.
- Conditions
- Nicotine Dependence
- Being tested
- Dual nicotine patch and electronic cigarette
- 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.
Dual nicotine patch and electronic cigaretteOther
| Study group | Role | What they receive |
|---|---|---|
| Dual nicotine patch and electronic cigarette | Experimental | Nicotine patch and the electronic cigarette will be administered. Receives: Other: Dual nicotine patch and electronic cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Cue Reactivity
Outcomes will be measured using a battery of self-report, neuroimagning, and behavioral measures of cue-reactivity.
Measured: 2 weeks after use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion24 Mar 2027 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
- Investigators
- Amy C Janes, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782599
- Sponsor's protocol ID
- E-cigarettes and Cues
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2013
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Janes AC, Pizzagalli DA, Richardt S, deB Frederick B, Chuzi S, Pachas G, Culhane MA, Holmes AJ, Fava M, Evins AE, Kaufman MJ. Brain reactivity to smoking cues prior to smoking cessation predicts ability to maintain tobacco abstinence. Biol Psychiatry. 2010 Apr 15;67(8):722-9. doi: 10.1016/j.biopsych.2009.12.034. Epub 2010 Feb 20.
PubMed 20172508Janes AC, Frederick Bd, Richardt S, Burbridge C, Merlo-Pich E, Renshaw PF, Evins AE, Fava M, Kaufman MJ. Brain fMRI reactivity to smoking-related images before and during extended smoking abstinence. Exp Clin Psychopharmacol. 2009 Dec;17(6):365-73. doi: 10.1037/a0017797.
PubMed 19968401
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarettes and Reactivity to Smoking Cues
- ClinicalTrials.gov ID
- NCT01782599
- Acronym / sponsor ID
- E-cigarettes and Cues
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 4 Feb 2013 (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 this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues.
Detailed description
Tobacco-related illness causes over 5 million deaths per year in the developed world, and most currently available smoking cessation treatments do not effectively enhance long-term cessation outcomes. Reactivity to smoking cues is one factor associated with relapse vulnerability, which is untreated by cessation aids such as NRT. Combining treatments, which ameliorate both pharmacological nicotine withdrawal and reduce smoking cue reactivity, may enhance smoking cessation success. During this study we will test whether combining NRT with non-nicotine containing electronic cigarettes (e-cigarettes) effectively reduces reactivity to smoking cues. The only source of nicotine participants will receive during the study will come from NRT. We will use e-cigarettes that provide no nicotine, yet may provide a similar experience to smoking as e-cigarettes taste and feel similar to a regular cigarette. However, since nicotine delivery is not associated with the act of smoking the reinforcing effects associated with smoking behavior may be reduced. Reactivity to smoking cues will be assessed using a battery of measures including: self-report, behavioral, and neuroimaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual nicotine patch and electronic cigarette | Experimental | Other: Dual nicotine patch and electronic cigaretteNicotine patch and the electronic cigarette will be administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written informed consent.
- Be aged 18-45.
- Report smoking cigarettes daily in the past 6 months.
- Have expired breath CO indicative of regular smoking.
- Have a score greater than 0 on the FTND.
Key exclusion criteria (9 listed)
- Be pregnant (measured via urinalysis).
- Meet current abuse or dependence criteria for any substance other than nicotine or caffeine (measured via the SCID 5).
- Produce a positive urine screen for drugs of abuse or alcohol at the fMRI scan visits.
- Meet DSM-IV criteria for major depressive episode in the past six months, lifetime DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder or psychotic disorders not elsewhere classified (measured via the SCID 5).
- Be currently suicidal as assessed by DSM 5 and the Beck Depression Inventory.
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 |
|---|---|---|
| Dual nicotine patch and electronic cigarette | Other | Dual nicotine patch and electronic cigarette |
Primary outcome
Reduction in Cue Reactivity
Time frame: 2 weeks after use
Outcomes will be measured using a battery of self-report, neuroimagning, and behavioral measures of cue-reactivity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 20172508Janes AC, Pizzagalli DA, Richardt S, deB Frederick B, Chuzi S, Pachas G, Culhane MA, Holmes AJ, Fava M, Evins AE, Kaufman MJ. Brain reactivity to smoking cues prior to smoking cessation predicts ability to maintain tobacco abstinence. Biol Psychiatry. 2010 Apr 15;67(8):722-9. doi: 10.1016/j.biopsych.2009.12.034. Epub 2010 Feb 20.
- Background: PubMed 19968401Janes AC, Frederick Bd, Richardt S, Burbridge C, Merlo-Pich E, Renshaw PF, Evins AE, Fava M, Kaufman MJ. Brain fMRI reactivity to smoking-related images before and during extended smoking abstinence. Exp Clin Psychopharmacol. 2009 Dec;17(6):365-73. doi: 10.1037/a0017797.
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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.
Amy C Janes, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual nicotine patch and electronic cigarette in people with Nicotine Dependence, run by Mclean Hospital 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction in Cue Reactivity (time frame: 2 weeks after use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782599, which also lists 2 linked publications.
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 14 Jul 2026.