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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

Guillaumier 2018.

Study characteristics
Methods Design: Pragmatic, open‐label, single‐centre, 2‐arm randomized controlled trial
Recruitment: Withdrawal service in Melbourne, Australia
Setting: Substance use disorder treatment setting, and following discharge, community setting, Melbourne, Australia
Study start date: 1 August 2017; Study end date: April 2019.
Participants Total N: 100
N per arm: EC intervention = 50; NRT Control = 50
Inclusion criteria:
  • Aged 18 years or over

  • Tobacco smoker on entering the residential service

  • Have the capacity to consent and able to understand the participant materials and follow the study instructions and procedures (e.g. sufficient English language ability)


Exclusion criteria:
  • Have used an END containing nicotine in the past month;

  • Currently pregnant or breast‐feeding (measured by self‐report);

  • Currently enrolled in another study;

  • Scheduled to be transferred to a long‐term rehabilitation unit following discharge from the residential withdrawal unit.


Inclusion based on specific population characteristic: Participants were discharged from a smoke‐free alcohol or other drugs (AOD) residential withdrawal service
32% women; mean age 40.9; mean cpd 21
Motivated to quit: Median (SD) = 7.3 (2.4) of 1 to 10 scale with 10 "highly motivated"
Interventions EC: Refillable.
Up to an hours training session, information pack. Innokin Endura T22 starter kit and refill liquid (Nicophar). 4‐week supply of liquid nicotine, with further supplies of liquid nicotine mailed twice at 4‐ week intervals. Dosing schedule of e‐liquid dependent nicotine dependence score: high‐nicotine‐dependence category assigned initial 4‐week e‐liquid supply (total 8 × 10 ml bottles) consisting of: 2 × 10 ml bottles of 18 mg e‐liquid and 6 × 10 ml bottles of 12 mg e‐liquid. The second and third batches = 8 × 10 ml bottles of 12 mg e‐liquid only. Participants scoring in the moderate‐ and low‐dependence categories: three 4‐week supplies of 8 × 10 ml bottles of 12 mg e‐liquid. Participants given 1‐week supply of nicotine patches for use while getting used to the EC.
NRT control: Information pack, 12 weeks NRT on the same schedule as for ENDs. 4‐week supply of patches plus a nicotine spray and inhaler, followed by refills including patches plus inhaler, gum and lozenges.
Both groups received proactive referral to quitline counseling (call‐back service), which provides calls at pre‐discharge and on days 1, 3, 7, 14 and 28 post‐discharge, with an emphasis on relapse prevention. Counsellors trained on the use of ENDs.
Outcomes Week 6, 12; self‐report.
Adverse events collected
Other outcomes measured:
  • Acceptability and feasibility of interventions

  • Treatment adherence

  • Cigarettes smoked per day ‐ Heaviness of Smoking Index

  • Frequency of cravings

  • Minnesota Nicotine Withdrawal Scale (MNWS)

  • 10‐item Kessler Psychological Distress Scale (Kessler‐10)

  • Quitting self‐efficacy, motivation to quit and the Heaviness of Smoking Index were assessed at baseline

Study funding "The study is supported by a VicHealth Innovation Research Grant (2016–0096). AG is supported by a post‐doctoral fellowship from the Heart Foundation. ALB is supported by an Australian National Health and Medical Research Council (NHMRC) senior research fellowship and a Faculty of Health and Medicine, University of Newcastle Gladys M Brawn senior research fellowship. BB is supported by an Australian NHMRC career development fellowship (GNT1063206) and a Faculty of Health and Medicine, University of Newcastle Gladys M Brawn career development fellowship."
"This study was supported by a VicHealth Innovation Research Grant (2016‐0096)."
Author declarations "The authors declare that they have no competing interests."
"None to declare."
Notes New for 2020 update; additional data originally provided by authors and subsequently published
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Upon completing the baseline survey, participants were randomised 1:1 to an intervention via a computer‐sequenced 4–6 block randomisation embedded in the tablet device software.”
Allocation concealment (selection bias) Low risk Quote: “At the end of the baseline survey, participants will be randomised 1:1 to an intervention via a computer‐sequenced 4–6 block randomisation embedded in the iPad.”
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: “Participants were informed of their intervention group by the RA and provided with a training session of up to one hour.”
“Due to the nature of the intervention, neither participants nor staff can be blinded to allocation. However, the data safety monitoring committee and the statistician responsible for the data analysis will be blinded.”
Blinding of outcome assessment (detection bias)
All outcomes High risk No biochemical validation, self‐report data
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: “At 6 and 12‐weeks, 63 participants (63%) and 50 participants (50%) were followed up, respectively. While slightly higher retention rates were evidence in the VNP group at 6‐weeks (68% vs 58% in NRT group; p=0.300); there were no differences between groups at 12‐weeks (25 recontacted in both arms; i.e., 50%).”
Selective reporting (reporting bias) Low risk Unpublished findings provided by authors report on all outcomes mentioned in the protocol