GENESIS study
Research type
Research Study
Full title
GENESIS Study: A 12-month randomised, double-blind, controlled, international multicentre trial comparing changes in Cigarette consumption after switchinG to high or low nicotine strENght E-cigaretteS In smokers with Schizophrenia spectrum disorders.
IRAS ID
291190
Contact name
Ramin Nilforooshan
Contact email
Sponsor organisation
ECLAT Srl
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This will be a multicenter, 12-months prospective trial, utilizing a randomized, double-blind, 2-arm parallel, switching design to compare effectiveness, tolerability, acceptability, and pattern of use between high (JUUL 5% nicotine) and low nicotine strength devices (JUUL 1.5% nicotine) in adult smokers with schizophrenia spectrum disorders. The study will take place at 5 sites- 1 single site in the UK and 4 sites in Italy.
Participants will be randomized (1:1 ratio) to either high (JUUL 5% nicotine) or low nicotine strength devices (JUUL 1.5% nicotine) study arm. The two devices have identical appearance and will be assigned in a double-blind fashion. Study products will be provided for a total of 6-months (intervention phase); the intervention phase will be followed by a further 6-month observational period (follow-up phase) during which no products will be dispensed to participants. Throughout the follow-up phase and up to the final visit at 12-months, changes in smoking/vaping behavior and in their pattern of use will be tracked under naturalistic condition and compared between study groups. Any changes in symptom severity related to schizophrenia spectrum disorders within and between both arms of the study will be monitored. The intervention phase of the study will consist of a total of nine visits (including screening). The follow-up phase will consist of three additional visits (two telephone contacts and one final face to face visit).
REC name
London - Surrey Research Ethics Committee
REC reference
21/LO/0416
Date of REC Opinion
15 Jul 2021
REC opinion
Further Information Favourable Opinion