ACTRN12619001787178.
| Study name | Project NEAT: nicotinE As Treatment for tobacco smoking following discharge from residential withdrawal services |
| Methods | RCT Project NEAT: A randomized controlled trial to examine the efficacy of vaporised nicotine products and telephone quit line support compared with nicotine replacement therapy and telephone quit line support when used following discharge from a residential withdrawal services Setting: Australia (New South Wales, Queensland, Victoria) Recruitment 4 hospitals sites: Belmont Hospital, Belmont; St Vincent's Hospital, Darlinghurst; Turning Point Drug and Alcohol Centre, Richmond; Royal Brisbane & Womens Hospital, Herston |
| Participants | Target sample size: 926 Inclusion criteria: • Aged 18 or over • Daily tobacco smoker (10 or more cigarettes) on entering withdrawal unit • Accessing treatment from participating services • Want to quit smoking in the next 30 days • 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). Exclusion criteria: • Pregnant or breast‐feeding • Enrolled in another study • Scheduled to be transferred to a long‐term residential rehabilitation service following discharge from the withdrawal unit • Used VNP (containing nicotine) in the last 30 days • Currently engaged in Quitline’s call‐back services • No ready access to a phone |
| Interventions | Condition One: Vaporised Nicotine Products and Quitline Condition Two: Current Best Practice Treatment for Tobacco Smoking (Combination Nicotine Replacement Therapy and Quitline) |
| Outcomes | 9 months after inpatient withdrawal unit discharge: Self‐reported 7 months continuous abstinence from tobacco smoking Biochemically‐verified 7‐month continuous abstinence from tobacco smoking 3 and 9 months after inpatient withdrawal unit discharge: 30‐day point prevalence abstinence 7‐day point prevalence abstinence Abstinence from all nicotine/ tobacco products |
| Starting date | Anticipated enrolment: 19 December 2019. Anticipated date last data collection 19 September 2022 |
| Contact information | Prof Billie Bonevski, Billie.Bonevski@newcastle.edu.au |
| Notes | Funding: National Health and Medical Research Council (grant number: G1800272), Canberra ACT 2601. |