Electronic Cigarettes and Reactivity to Smoking Cues

Nicotine Dependence Clinical Trial

Official title:

Electronic Cigarettes and Reactivity to Smoking Cues

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782599
• Other study ID #: E-cigarettes and Cues
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Mclean Hospital
• Contact: Maya Zegel, BA
• Phone: 617-855-3682
• Email: mzegel[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• Dual nicotine patch and electronic cigarette

Locations

Country	Name	City	State
United States	Mclean Hospital Imaging Center	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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