None listed
Conditions
Brief summary
Vaporised nicotine products (VNPs or electronic cigarettes) hold significant potential as both cessation aids and harm reduction support for people who smoke tobacco. It is important to determine the efficacy of novel strategies compared to current best practice treatment, Nicotine Replacement Therapy (NRT) and telephone Quitline. The aim of this world-first trial is to test the effectiveness of VNPs in conjunction with telephone Quitline at increasing smoking cessation amongst individuals receiving treatment at alcohol and other drug (AOD) residential withdrawal services compared to current best practice treatment (NRT and Quitline). Service users from six residential and inpatient withdrawal AOD services across three states (NSW, Victoria and Queensland) will be recruited and randomised. The intervention will be provided for 3-months post-discharge. Surveys will be conducted at 3 and 9-months post discharge and examine smoking cessation related variables.
Interventions
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;
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. Check-in calls scheduled during weeks 1-10 post discharge will provide an opportunity to assess adherence with the allocated study products and opportunity to provide re-fills. Self-reported use of the VNP, NRT patches, and Quitline will also be gathered during the 3-month and 9-month follow-up surveys. Participants do not need to utilise all VNP, NRT patches, or Quitline for the entire study period to be able to participate.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 breastfeeding • 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
Outcome results
None listed