Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

Nicotine Withdrawal Clinical Trial

— SenRep  

Official title:

The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414998
• Other study ID #: qmul1606
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: March 19, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Withdrawal

Intervention

Behavioral:
• Stress Ball vs Nicotine-free E-Cigarette
In a cross over design, participants will be randomly allocated to: 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. 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.
• Nicotine-free E-Cigarette vs De-nicotinised Cigarette
In a cross over design, participants will be randomly allocated to: 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. 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.

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urge to smoke at 10 minutes post product use	Urges to smoke will be measured at 10 minutes after use of products	10 minutes	No
Secondary	Tobacco withdrawal symptom ratings over 1 hour	Change withdrawal ratings one hour after product use	1 hour	No
Secondary	Tobacco withdrawal symptom ratings over one day	Change in tobacco withdrawal symptom ratings over a day	1 day	No