Using e-cigarettes to reduce smoking cue reactivity

Electronic Cigarettes and Reactivity to Smoking Cues

This study is testing if using non-nicotine e-cigarettes along with nicotine replacement therapy can help people who are dependent on nicotine feel less triggered by smoking cues and improve their chances of quitting smoking.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Mclean Hospital (Academic / other)
• Locations: 1 site (Belmont, Massachusetts)
• Trial ID: NCT01782599 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether non-nicotine electronic cigarettes can help reduce reactivity to smoking-related cues in individuals with nicotine dependence. Participants will use a combination of nicotine replacement therapy (NRT) and e-cigarettes that do not contain nicotine over a period of 2 to 3 weeks. The study will assess reactivity to smoking cues through self-reports, behavioral measures, and neuroimaging techniques. The goal is to determine if this combined approach can enhance smoking cessation success by addressing both nicotine withdrawal and cue reactivity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-45 who have been daily smokers for the past 6 months and are willing to use NRT and e-cigarettes.

Not a fit: Patients who are pregnant or have a history of substance abuse or certain mental health disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve smoking cessation outcomes for individuals struggling with nicotine dependence.

How similar studies have performed: While the combination of NRT and e-cigarettes is a novel approach, similar studies have shown promise in addressing smoking cue reactivity.

Eligibility criteria

Inclusion Criteria:

1. Provide written informed consent.
2. Be aged 18-45.
3. Report smoking cigarettes daily in the past 6 months.
4. Have expired breath CO indicative of regular smoking.
5. Have a score greater than 0 on the FTND.
6. Be willing to use Nicotine Replacement Therapy (NRT) and the e-cigarette for a period of 2 to 3 weeks.
7. Speak and read English.
8. Pass an MRI safety screen and meet inclusion criteria for MRI scans.

Exclusion Criteria:

1. Be pregnant (measured via urinalysis).
2. Meet current abuse or dependence criteria for any substance other than nicotine or caffeine (measured via the SCID 5).
3. Produce a positive urine screen for drugs of abuse or alcohol at the fMRI scan visits.
4. 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).
5. Be currently suicidal as assessed by DSM 5 and the Beck Depression Inventory.
6. 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).
7. MRI exclusion criteria. (additional information outlined in the "protection of human subjects" section).
8. History of claustrophobia.
9. History of propylene glycol sensitivity/allergy.

Where this trial is running

Belmont, Massachusetts

• Mclean Hospital Imaging Center — Belmont, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Amy C Janes, PhD — Mclean Hospital
• Study coordinator: Maya Zegel, BA

Conditions Nicotine Dependence