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. There is now good evidence of safety, and emerging evidence that VNPs assist cessation. More evidence of the safety and effectiveness of VNPs for populations (such as persons who use drugs) with high smoking prevalence rates and low quit rates is desperately needed. Further it is important to determine the efficacy of novel strategies compared to current best practice treatment, Nicotine Replacement Therapy (NRT). The aim of this trial is to test the effectiveness of VNPs at increasing smoking cessation amongst opiate agonist treatment (OAT) clients receiving treatment at alcohol and other drug (AOD) services across NSW Local Health Districts/Networks (LHD/Ns), compared to current best practice treatment (NRT). Service users from six LHD/Ns across NSW will be recruited and randomised.
Interventions
HARMONY:
This is a randomised single blinded parallel group trial comparing a 12-week course of liquid nicotine delivered via Vaporised Nicotine Product (VNP) to best practice Nicotine Replacement Therapy (NRT) in a 1:1 ratio.
Condition 1: VNP
Participants randomised to Condition 1 shall be supplied with a VNP (Innokin Endura T18-II starter kit) and 12 weeks of prescribed liquid nicotine (Nicophar).
A one-week supply of (NRT) transdermal patches shall also be provided to participants randomis
HARMONY: This is a randomised single blinded parallel group trial comparing a 12-week course of liquid nicotine delivered via Vaporised Nicotine Product (VNP) to best practice Nicotine Replacement Therapy (NRT) in a 1:1 ratio. Condition 1: VNP Participants randomised to Condition 1 shall be supplied with a VNP (Innokin Endura T18-II starter kit) and 12 weeks of prescribed liquid nicotine (Nicophar). A one-week supply of (NRT) transdermal patches shall also be provided to participants randomised to Condition 1 for use whilst they are learning how to use the VNP effectively. Participants can use the VNP at their discretion, as they would smoke a cigarette. In addition to the VNP, liquid nicotine and NRT patches, participants will be shown the New Zealand website https://vapingfacts.health.nz/ and encouraged to visit the site as an online resource throughout the trial. Participants will also receive training in the forms of brief videos, information pamphlets, user manuals and interactive discussions with research staff. Condition 1: VNP • Device loaded with one bottle of 12mg/ml e-liquid • An additional seven (7) bottles of 12mg/ml e-liquid • A brief information session on how to use the VNP • A VNP information pack including safe storage of e-liquid nicotine and disposal • 1-week supply of nicotine patches • Training on the use of NRT patches. • Where possible, ensure that participant uses the VNP before leaving and leaves wearing an NRT patch. Adherence will be measured via questionnaires.
Sponsors
Hunter New England Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria • Provide written, informed consent to participate in the study. • Aged 18 to 65 years • Be accessing opioid agonist treatment from a participating service • Current daily tobacco smokers on self-report • Want to quit or cut down their tobacco smoking • Be willing and able to comply with requirements of study (including having access to a phone)
Exclusion criteria
• Currently breastfeeding or pregnant, or of childbearing potential and planning/trying to fall pregnant during the study period • Current, severe medical disorder assessed by study medical officer (such as but not limited to, unstable cardiovascular/peripheral vascular disease, poorly controlled hypertension) • Current, severe and unstable psychiatric disorder assessed by study medical officer (such as but not limited to, acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others) • Current enrollment in a clinical trial involving any investigational drug • Regular use (more than one day per week) of VNP or e-Cigarette containing nicotine in the last 30 days • Not available for follow-up (e.g. likely imprisonment or transfer out of service to another service that is not a trial recruitment site)
Outcome results
None listed