ACTRN12621000148875.

Study name	HARMONY: harm reduction for Opiates, Nicotine and You
Methods	Design: randomized single‐blinded parallel group trial
Participants	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)
Interventions	Comparison of a 12‐week course of liquid nicotine delivered via Vaporised Nicotine Product (VNP) to best practice Nicotine Replacement Therapy (NRT) Condition 1: VNP (Innokin Endura T18‐II starter kit) • Device loaded with one bottle of 12 mg/ml e‐liquid • An additional seven (7) bottles of 12 mg/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.  In addition to the VNP, liquid nicotine and NRT patches, participants will be shown the New Zealand website 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
Outcomes	PRIMARY OUTCOME: Self‐reported 7‐day PPA from tobacco smoking assessed the following dichotomous question “In the last 7 days, have you smoked a cigarette, even a puff?;  [Week 12] SECONDARY OUTCOME: A cost consequence study setting out detailed comparative costs of treatments ‐ from the perspective of healthcare provider and; primary and secondary outcomes of the VNP and NRT Adverse events recorded Biochemically‐verified PPA; This will be measured via a CO monitor breath test for participants who self‐report 7‐day PPA at end of treatment [Week 12]  Changes in nicotine craving and withdrawal symptoms
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