RECRUITING

Electronic Cigarettes and Reactivity to Smoking Cues

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Electronic Cigarettes and Reactivity to Smoking Cues

Quick Facts

Study Start:2013-01

Study Completion:2024-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01782599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Maya Zegel, BA

CONTACT

617-855-3682

mzegel@mclean.harvard.edu

Principal Investigator

Amy C Janes, PhD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Study Locations (Sites)

Mclean Hospital Imaging Center

Belmont, Massachusetts, 02478

United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Amy C Janes, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-01

Study Completion Date2024-10-01

Study Record Updates

Study Start Date2013-01

Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

Nicotine Dependence