Effect of the Electronic Cigarette on Withdrawal Symptoms

NCT ID: NCT01454362

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-03-31

Brief Summary

Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and may have a potential to assist smoking cessation. Among current treatments for smokers, only the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does not exceed that of the other nicotine replacement therapy (NRT) products, but it mimics the relevant sensory input to only a limited extent, and its nicotine delivery is dependent on intensive puffing. Recently a new product, the Electronic Cigarette (E-C) has become available, which provides a more realistic behaviour and sensory replacement for smoking and can provide good nicotine levels with less effort.

Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco withdrawal symptoms over 24hr abstinence.

Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and craving and elicit more favorable user ratings. It will also provide higher nicotine levels.

Study design: In a cross-over study, participants will be randomized to the sequence of conditions and provide baseline measures and samples for salivary cotinine analysis. They will be asked to abstain from smoking their usual cigarettes and use the allocated product over 24 hours. They will return to the study centre the following day, and complete measures of craving and withdrawal, ratings of subjective and sensory effects of the products, product satisfaction, and adverse effects. They will also provide saliva samples for cotinine analysis. Abstinence from smoking will be verified with CO readings.

Detailed Description

There is considerable interest in E-Cs at the moment and the study would provide information on whether the E-C surpasses the tried and tested nicotine inhalator. If so, it would open a possibility of its utilization in smoking cessation, and provide encouragement for further examination of the role of sensorimotor replacements in the treatment of tobacco dependence.

Conditions

Mental and Behavioral Disorders; Withdrawal State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Electronic cigarette

We analysed 15 brands of the most popular E-Cs in the UK, EU and US for nicotine levels in the mist. Vapours were generated from cartridges of various nicotine content using a standard single-port linear smoking machine with a puff volume of 70 ml, 1 puff every 7 sec., and a puff duration of 1.8 sec (based on averaged puffing conditions from 10 E-C users found during preliminary studies). Nicotine was absorbed in two sequential washing bottles with methanol and internal standards and analysed with gas chromatography. One brand was selected for this study as it consistently delivers about 1mg of nicotine with 20 puffs.

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

Inhalation of nicotine.

Nicotine Inhalator

The inhalator consists of a nicotine cartridge which is placed into a plastic mouthpiece. One cartridge contains 10mg of nicotine of which 4mg of nicotine can be extracted. Nicotine is delivered mainly through the oral cavity, throat, and upper respiratory tract with a minor fraction reaching the lungs. A single cartridge can be used for one 20-minute period of continuous puffing or periodic use of up to 400 puffs per cartridge.

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

Inhalation of nicotine.

Interventions

Nicotine

Inhalation of nicotine.

Intervention Type: DRUG

Other Intervention Names

Nicorette inhalator

Eligibility Criteria

Inclusion Criteria

• Volunteers smoking at least 12 cigarettes per day
• First cigarette smoked within 60 minutes of waking up
• Willing to abstain from smoking for one day in 2 consecutive weeks.

Exclusion Criteria

• Under 18 years of age
• Current psychiatric illness
• Pregnant or breastfeeding
• Enrollment in other research projects
• Used electronic cigarette and/or nicotine inhalator before

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Hayden McRobbie

Reader in Public Health Interventions

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hayden J McRobbie, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Tobacco Dependence Research Unit

London, , United Kingdom

Countries

United Kingdom

References

West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.

Reference Type: BACKGROUND

PMID: 15179542 (View on PubMed)

West RJ, Hajek P, Belcher M. Severity of withdrawal symptoms as a predictor of outcome of an attempt to quit smoking. Psychol Med. 1989 Nov;19(4):981-5. doi: 10.1017/s0033291700005705.

Reference Type: BACKGROUND

PMID: 2594893 (View on PubMed)

Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Multivariate framework of the Brief Questionnaire of Smoking Urges. Drug Alcohol Depend. 2007 Oct 8;90(2-3):234-42. doi: 10.1016/j.drugalcdep.2007.04.002. Epub 2007 May 7.

Reference Type: BACKGROUND

PMID: 17482773 (View on PubMed)

Rose JE, Behm FM, Westman EC, Bates JE, Salley A. Pharmacologic and sensorimotor components of satiation in cigarette smoking. Pharmacol Biochem Behav. 2003 Sep;76(2):243-50. doi: 10.1016/j.pbb.2003.07.002.

Reference Type: BACKGROUND

PMID: 14592675 (View on PubMed)

Other Identifiers

2011-005565-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1127-4445

Identifier Type: OTHER

Identifier Source: secondary_id

QMUL111111

Identifier Type: -

Identifier Source: org_study_id