East Lancashire Vaping Pilot RCT V1
Research type
Research Study
Full title
A pilot randomized controlled trial of the effectiveness of e-cigarettes for tobacco smoking cessation and harm reduction in (treated) opiate use disorder.
IRAS ID
311370
Contact name
Zoe Welch
Contact email
Sponsor organisation
Change Grow Live
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
The pilot aims to determine the feasibility of conducting a full RCT in this population and to collect data to inform the success of a full RCT. The pilot also aims to evaluate whether, in treated opiate users who smoke tobacco, the offer of an e-cigarette is associated with tobacco abstinence at 12 weeks compared with treatment as usual (TAU) and if this improvement is associated with better quality of life, improved health and substance use outcomes and reduced health and social care costs.
UK drug policy emphasises the importance of smoking cessation in substance use treatment, but the prevalence of tobacco smoking is as high as 61% in treated opiate users. This compares to a UK general population rate of 14.1%. E-cigarettes are a frequently-used option for smoking cessation – RCT data point to their effectiveness in adults in the general population. But there is an absence of robust data on smoking quit attempts supported by e-cigarettes specifically in (treated) opiate users.
The intervention arm will consist of treatment as usual (TAU) plus the provision of an e-cigarette (plus e-liquids for 4 weeks). TAU is defined as current Change Grow Live service provision, i.e. people can be referred to local smoking cessation services where they could receive nicotine replacement therapy (NRT), consisting of patches and/or gum, but not e-cigarettes. The non-intervention arm will consist of TAU only.
The pilot will take place in the Inspire East Lancashire Change Grow Live service.
The high prevalence (61%) of tobacco smoking in treated opiate users provides a substantial pool of potential participants. Recruitment will not be restricted to tobacco smokers who explicitly want to quit, meaning that the majority of individuals in this pool represent potential participants.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0113
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion