Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes (SenRep)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dunja Przulj, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01414998
First received: August 10, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.

Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.

Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).

The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.


Condition Intervention
Nicotine Withdrawal
Behavioral: Stress Ball vs Nicotine-free E-Cigarette
Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Urge to smoke at 10 minutes post product use [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Urges to smoke will be measured at 10 minutes after use of products


Secondary Outcome Measures:
  • Tobacco withdrawal symptom ratings over 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Change withdrawal ratings one hour after product use

  • Tobacco withdrawal symptom ratings over one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Change in tobacco withdrawal symptom ratings over a day


Estimated Enrollment: 120
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stress Ball
This is the active comparator for study 1
Behavioral: Stress Ball vs Nicotine-free E-Cigarette

In a cross over design, participants will be randomly allocated to:

  1. use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre.
  2. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.

One week later participants will complete the other arm.

Experimental: De-nicotinised Cigarette
This will be the experimental arm for study 2
Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

In a cross over design, participants will be randomly allocated to:

  1. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
  2. smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre.

One week later participants will complete the other arm.

Experimental: Nicotine-free Electronic Cigarette (1)
This will be the experimental arm for study 1
Behavioral: Stress Ball vs Nicotine-free E-Cigarette

In a cross over design, participants will be randomly allocated to:

  1. use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre.
  2. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.

One week later participants will complete the other arm.

Active Comparator: Nicotine-free Electronic Cigarette (2)
This will be the active comparator for study 2
Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

In a cross over design, participants will be randomly allocated to:

  1. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
  2. smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre.

One week later participants will complete the other arm.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or over
  • Smokes at least 10 cigarettes per day
  • Smokes first cigarette within 1 hour of waking

Exclusion Criteria:

  • pregnant or breastfeeding
  • acute psychiatric illness
  • currently enrolled in other research projects
  • current use of ECs or Denics
  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: NCT01414998

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

No publications provided

Responsible Party: Dunja Przulj, Prinicipal Investigator, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01414998     History of Changes
Other Study ID Numbers: qmul1606
Study First Received: August 10, 2011
Last Updated: March 19, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014