NCT01782599

Brief Summary

The purpose of this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

11.8 years

First QC Date

January 30, 2013

Last Update Submit

January 3, 2024

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • Reduction in Cue Reactivity

    Outcomes will be measured using a battery of self-report, neuroimagning, and behavioral measures of cue-reactivity.

    2 weeks after use

Study Arms (1)

Dual nicotine patch and electronic cigarette

EXPERIMENTAL

Nicotine patch and the electronic cigarette will be administered.

Other: Dual nicotine patch and electronic cigarette

Interventions

Dual nicotine patch and electronic cigaretteOTHER
Dual nicotine patch and electronic cigarette

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • History of claustrophobia.
  • History of propylene glycol sensitivity/allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mclean Hospital Imaging Center

Belmont, Massachusetts, 02478, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20172508BACKGROUND

  • Janes 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.

    PMID: 19968401BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Amy C Janes, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Zegel, BA

CONTACT

617-855-3682mzegel@mclean.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, HMS and Director, McLean Imaging Center

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 4, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

US(1)