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. |
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Participants | Total N: 100 N per arm: EC intervention = 50; NRT Control = 50 Inclusion criteria:
Exclusion criteria:
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" |
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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. |
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Outcomes | Week 6, 12; self‐report. Adverse events collected Other outcomes measured:
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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)." |
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Author declarations | "The authors declare that they have no competing interests." "None to declare." |
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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 |