Project NEAT: NicotinE As Treatment for tobacco smoking following discharge from residential withdrawal services.

INTERVENTION: Condition One: Vaporised Nicotine Products and Quitline. Participants randomised to condition one will receive the following: 1) An information pack with study resources specifically designed by the investigators for the present study that include: a one page user VNP guide and a brochure that documents benefits of quitting smoking and tips on how to use the VNP, a study wallet card with trial number and study project phone line, letter to GP about study participation, brochure about Quitline; 2) Provision of two VNP kits (Innokin T18‐II device); 3) A prescription of nicophar nicotine e‐liquid (12mg/10ml) for 12‐weeks. One initial and two re‐fill prescriptions will be provided. A total of 24 units over the 12 weeks. The e‐liquid containing nicotine is manufactured to GMP standards for the trial (Nicophar brand). It will be provided to participants in 10ml dropper bottles. Each 12mg strength 10ml bottle will contain nicotine (1.2%), vegetable glycerol (84%), and water (14.8%). Participants will be instructed to only use the study provided e‐liquid in the provided device. Participants will be advised to use the VNPs ad libitum i.e. as and when required; 4) A one week supply of 21mg nicotine patches (7 patches to use for 7 days) will be provided to participants of the study. Participants will be encouraged to utilise the patches for the first week following discharge from the inpatient withdrawal service while they become accustomed to utilising the device; 5) Proactive referral to Quitline counselling (call‐back service) which provides one call during their inpatient withdrawal treatment and then calls post discharge at days 1, 3, 7, 14 & 28 post‐discharge, with an emphasis on relapse prevention. Average Quitline call is about 10‐20 minutes, however, the total number and timing of calls will be tailored to client need and smoking status, i.e. more frequent calls around relapse crises/quit attempts with an approximate 10 calls over 12 weeks. CONDITION: Mental Health ‐ Addiction Public Health ‐ Other public health Tobacco smoking; ; Tobacco smoking PRIMARY OUTCOME: Self‐reported 7 months continuous abstinence from tobacco smoking; This will be measured utilising a number of items specifically created for this study. Items include: a) duration since quitting smoking; b) occasions of smoking since quitting; c) occasions of smoking for a week; d) duration to week long relapse. These items together will inform whether individuals meet self‐reported 7‐month continuous abstinence from tobacco smoking. [9 months after inpatient withdrawal unit discharge] SECONDARY OUTCOME: 30 day point prevalence abstinence ; A composite measure will be used. The first item will ask participants "Have you smoked at all, even a puff, in the last 30 days?" with response options a) yes, b) no. A second measure will ask participants "How many cigarettes have you smoked in the last 30 days?" with response options a) less than 1 or just a puff; b) 1‐5; c) 6‐10; d) 11‐20; More than 20. Both measures will be self‐reported 30 day point prevalence abstinence and refers to the 30 days preceding the follow‐up period in which the question is asked. [3 and 9 months after inpatient withdrawal unit discharge] 7 day point prevalence abstinence INCLUSION CRITERIA: • Aged 18 or over • Daily tobacco smoker (10 or more cigarettes) on entering withdrawal unit • Accessing treatment from participating services â���¢ Want to quit smoking in the next 30 days ; This will be measured by asking participants "Have you smoked at all, even a puff, in the last 7 days?" with response options a) yes, b) no. This will be self‐reported 7 day point prevalence abstinence and refers to the 7 days preceding the follow‐up period in which the question is asked. [3 and 9 months after inpatient withdrawal unit discharge] Abstinence from all nicotine/ tobacco products ; This will be measured by asking participants "Are you currently using any form of nicotine products, including vaporised nicotine products and tobacco products other than cigarettes? with response options a) no; b) yes, nicotine patches; c) yes, oral nicotine products; d) yes, nicotine vaping products; e) yes, some other form of tobacco product. [3 and 9 months after inpatient withdrawal unit discharge] Biochemically verified 7 month continuous abstinence from tobacco smoking ; A participant reporting that they have quit smoking for the last 7 months and have smoked on five or less than 5 occasions or not at all will be asked to complete a bedfront smokelyzer breath test to measure expired carbon monoxide (CO). A participant with a CO level less than 8ppm will be considered abstinent. The bedfont smokelyzer breath test will be conducted by a trained research assistant.[9 months after inpatient withdrawal unit discharge] Cravings to smoke ; A composite measure will be used that examines frequency of cravings and strength or cravings as recommended in the smoking cessation literature. Frequency of cravings will be measured by asking participants "How often do you get cravings to smoke tobacco?" with response options: a) hourly or more often, b) several times per day, c) at least once a day, d) less than daily, e) never. Strength of cravings will be measured by asking participants "How strong have these urges been?" with response options: a) no urge, b) slight, c) moderate, d) strong, e) very strong, f) extremely strong.[3 and 9 months after inpatient withdrawal unit discharge] Number of cigarettes smoked ; Participants will be asked "currently how many cigarettes do you smoke‐ per day, per week, and per month?". A reduction in the number of cigarettes per day, week, or month will be assessed compared to baseline. [ 3 and 9 months after inpatient withdrawal unit discharge] Relapse episodes ; Relapse to tobacco smoking will be assessed by a composite measure designed for the study. The first measure will ask participants "Have you smoked at all since you quit?" with response options a) yes on more than 5 occasions; b) yes but on 5 or less occasions; c) no. The second measure will ask participants "Since you quit smoking, have you smoked every day for a week or more (even just puffs)" with response options a) yes; b) no; c) don't know; d) refused to answer. The third measure will ask participants "We need to start counting your quit attempt from the end of the last period when you smoked for a week or more" with response options a) 1 week to 1 month; b) 1‐3 months; c) 3‐6 months; d) More than 6 months. [3 and 9 months after inpatient withdrawal unit discharge] Withdrawal symptoms ; Assessment of withdrawal and psychological distress compared to baseline will be conducted using a measure that combines the Patient Health Questionnaire (PHQ‐4) and Minnesota Nicotine Withdrawal Scale. [3 and 9 months after inpatient withdrawal unit discharge] • Has capacity to consent and able to understand the participant materials and follow the study instructions and procedure (e.g. sufficient English language ability and not too unwell as judged by medical staff)