Electronic Cigarettes and Reactivity to Smoking Cues

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
Amy C. Janes, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01782599
First received: January 30, 2013
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Nicotine Dependence
Other: Dual nicotine patch and electronic cigarette

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Electronic Cigarettes and Reactivity to Smoking Cues

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Reduction in Cue Reactivity [ Time Frame: 2 weeks after use ] [ Designated as safety issue: No ]
    Outcomes will be measured using a battery of self-report, neuroimagning, and behavioral measures of cue-reactivity.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual nicotine patch and electronic cigarette
Nicotine patch and the electronic Cigarette will be administered.
Other: Dual nicotine patch and electronic cigarette

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 air CO of approximately 10 ppm on the first fMRI scan day.
  5. Meet DSM-IV criteria for current nicotine dependence (measured via the SCID-I/R- Research Version).
  6. Have a score of 4 or greater on the FTND
  7. Be willing to use Nicotine Replacement Therapy (NRT) and the e-cigarette for a period of 2 to 3 weeks
  8. Speak and read English.
  9. 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-I/R-Research Version).
  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-I/NP).
  5. Be currently suicidal as assessed by DSM-IV 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782599

Contacts
Contact: Stacey Farmer, BA 617-855-2359 Stacey Farmer <sfarmer@mclean.harvard.edu>

Locations
United States, Massachusetts
Mclean Hospital Imaging Center Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Stacey Farmer, BA    617-855-2359      
Principal Investigator: AMy C Janes, PhD         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Amy C Janes, PhD Mclean Hospital
  More Information

Publications:
Responsible Party: Amy C. Janes, Assistant Professor/Associate Neuroscientist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01782599     History of Changes
Other Study ID Numbers: E-cigarettes and Cues
Study First Received: January 30, 2013
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014