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Electronic Cigarettes and Reactivity to Smoking Cues

Primary Purpose

Nicotine Dependence

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dual nicotine patch and electronic cigarette

About this trial

This is an interventional basic science trial for Nicotine Dependence

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
MRI exclusion criteria. (additional information outlined in the "protection of human subjects" section).
History of claustrophobia.
History of propylene glycol sensitivity/allergy.

Sites / Locations

Mclean Hospital Imaging CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dual nicotine patch and electronic cigarette

Arm Description

Nicotine patch and the electronic cigarette will be administered.

Outcomes

Primary Outcome Measures

Reduction in Cue Reactivity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01782599

First Posted

January 30, 2013

Last Updated

October 29, 2021

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01782599

Brief Title

Electronic Cigarettes and Reactivity to Smoking Cues

Official Title

Electronic Cigarettes and Reactivity to Smoking Cues

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dual nicotine patch and electronic cigarette

Arm Type

Experimental

Arm Description

Nicotine patch and the electronic cigarette will be administered.

Intervention Type

Other

Intervention Name(s)

Dual nicotine patch and electronic cigarette

Primary Outcome Measure Information:

Title

Reduction in Cue Reactivity

Description

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

Time Frame

2 weeks after use

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). MRI exclusion criteria. (additional information outlined in the "protection of human subjects" section). History of claustrophobia. History of propylene glycol sensitivity/allergy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maya Zegel, BA

Phone

617-855-3682

mzegel@mclean.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy C Janes, PhD

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mclean Hospital Imaging Center

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maya Zegel, BA

Phone

617-855-3682

First Name & Middle Initial & Last Name & Degree

Amy C Janes, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20172508

Citation

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. Erratum In: Biol Psychiatry. 2010 May 15;67(10):1002.

Results Reference

background

PubMed Identifier

19968401

Citation

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. Erratum In: Exp Clin Psychopharmacol. 2010 Jun;18(3):296.

Results Reference

background

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Electronic Cigarettes and Reactivity to Smoking Cues

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