Effect of the Electronic Cigarette on Withdrawal Symptoms (ECIG24)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hayden McRobbie, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01454362
First received: October 12, 2011
Last updated: April 21, 2013
Last verified: April 2013
  Purpose

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 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.


Condition Intervention
Mental and Behavioral Disorders
Withdrawal State
Drug: Nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 4 Study to Compare of the Effects of the Electronic Cigarette and Nicotine Inhalator on Tobacco Withdrawal Symptoms Over 24 Hours of Abstinence

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Comparison of E-C and inhalator in effects on withdrawal over 24 hours of use. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Mood and Physical Symptoms Scale (MPSS; West & Hajek, 2004): Measure of severity of urges to smoke and tobacco withdrawal symptoms. MPSS is a rating scale sensitive to tobacco, and to both pharmacological (West, Hajek et al. 1990) and behavioral (McRobbie and Hajek 2007) treatment effects. Effective treatments typically generate a difference in ratings over 24-hours of abstinence of at least 0.7 compared to control procedures.


Secondary Outcome Measures:
  • Adverse effects after 24-hour use. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Adverse effects questionnaire: Measure of the occurrence and severity of any side effects.

  • Salivary cotinine levels after 24-hour use. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Cotinine is a measure sensitive enough to detect effects of a switch to different nicotine products and salivary cotinine was shown to be dependent on nicotine mouth exposure.

  • Reinforcing effects of smoking [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al, 2007): Measure of reinforcing effects of smoking.

  • Airway sensations [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Sensory effects (Rose & Behm, 2004):Measure of airway sensations

  • Adverse effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Adverse effects questionnaire (adapted from Hajek et al, 1989): Measure of the occurrence and severity of any side effects.

  • Product satisfaction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Product satisfaction (adapted from Hajek et al, 1989): Ratings of product satisfaction and helpfulness.


Enrollment: 60
Study Start Date: December 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Nicotine
Inhalation of nicotine.
Other Name: Nicorette inhalator
Active Comparator: 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.
Drug: Nicotine
Inhalation of nicotine.
Other Name: Nicorette inhalator

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01454362

Locations
United Kingdom
Tobacco Dependence Research Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Hayden J McRobbie, PhD Queen Mary University of London
  More Information

Additional Information:
Publications:
Responsible Party: Hayden McRobbie, Reader in Public Health Interventions, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01454362     History of Changes
Other Study ID Numbers: QMUL111111, 2011-005565-20, U1111-1127-4445
Study First Received: October 12, 2011
Last Updated: April 21, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen Mary University of London:
nicotine
inhalator
electronic cigarette
tobacco

Additional relevant MeSH terms:
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 September 30, 2014