Effect of the Electronic Cigarette on Withdrawal Symptoms

NCT01454362 | Completed Results DMC

• 3 other identifiers: QMUL1111112011-005565-20U1111-1127-4445
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental and Behavioral Disorders; Withdrawal State

Keywords

nicotine; inhalator; electronic cigarette; tobacco

Outcome Measures

Primary Outcomes (1)

• Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.

  Mood and Physical Symptoms Scale (MPSS): Measure of severity of urges to smoke and tobacco withdrawal symptoms. A five-point scale is used to rate 'How much of the time have you felt the urge to smoke in the past week?' ((1) 'not at all' to (5) 'almost all of the time') and 'How strong have the urges been?' ('no urges' to 'very strong'). Clients also rate depression, irritability, restlessness, hunger, poor concentration, poor sleep at night, and anxiety during the past week ((1)=not at all to (5)=extremely). The combined score to questions on depression, irritability, restlessness, hunger, and poor concentration are averaged to give the MPSS score. A higher score means a more severe rating of withdrawal. The primary outcome is a change in MPSS score between baseline and 24 hours (value at 24 hours minus value at baseline). Therefore, a smaller change in MPSS score represents a smaller increase in tobacco withdrawal symptoms.

  24 hours

Secondary Outcomes (4)

• Change in Salivary Cotinine Levels After 24-hour Use.

  24 hours

• Reinforcing Effects of Smoking

  24 hours

• Airway Sensations

  24 hours

• Product Satisfaction

  24 hours

Study Arms (2)

Electronic cigarette

EXPERIMENTAL

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.

Drug: Nicotine

Nicotine Inhalator

ACTIVE COMPARATOR

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.

Drug: Nicotine

Interventions

Nicotine DRUG

Inhalation of nicotine.

Also known as: Nicorette inhalator

Electronic cigarette; Nicotine Inhalator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 15179542 BACKGROUND

• 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.

  PMID: 2594893 BACKGROUND

• 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.

  PMID: 17482773 BACKGROUND

• 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.

  PMID: 14592675 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Vaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr Hayden McRobbie
• Organization: Queen Mary University of London

researchamendments@bartsandthelondon.nhs.uk

0207 882 7260

Study Officials

• Hayden J McRobbie, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Public Health Interventions

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 19, 2011
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 27, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Locations

GB (1)