ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001787178

Ethics application status

Approved

Date submitted

18/11/2019

Date registered

17/12/2019

Date last updated

2/05/2022

Date data sharing statement initially provided

17/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Project NEAT: NicotinE As Treatment for tobacco smoking following discharge from residential withdrawal services.

Scientific title

Project NEAT: A randomized controlled trial to examine the efficacy of Vaporised nicotine products and telephone quit line support compared with nicotine replacement therapy and telephone quit line support when used following discharge from a residential withdrawal services.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Project NEAT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tobacco smoking

Condition category

Condition code

Public Health

Other public health

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Treatment: Devices

Intervention code [3]

Behaviour

Comparator / control treatment

An active control condition will be used as it reflects what is expected of AOD services as part of routine care (but may not be routinely delivered).

Condition Two: Current Best Practice Treatment for Tobacco Smoking (Combination Nicotine Replacement Therapy and Quitline). Participants randomised to condition two 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 NRT guide and a brochure that documents benefits of quitting smoking and tips on how to use NRT;
2) Provision of 12 weeks of nicotine replacement therapy – transdermal (e.g. patches) and oromucosal forms (e.g. gum, lozenge, mouth spray) of NRT to be used throughout the intervention period. For weeks 1-4 participants will receive: 4 x QuitX 21mg Patches 7s, 2 x Nicorette Inahaltor 15mg 20s, and 3 x Nicorette Quick Mist 1mg spray. For weeks 5-8 participants will receive: 4 x QuitX 21mg Patches 7s, 2 x Nicorette Inhalator 15mg 20s, 1 x Nicorette Cool Drops 4mg 80s, and 1 x quitX Gum 4mg 100s Mint. For weeks 9-12 participants will receive 1 x Nicabate 21mg Patches 28s, 2 x Nicorette Inhalator 15mg 20, 2 x Nicorette Cool Drops 4mg 80s. Participants will be advised to use the NRT ad libitum i.e. as and when required. This will be mailed to an address the participant supplies;
3) 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. 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. Participants will be text messaged to alert them to expect a Quitline call prior to being called as AOD clients are unlikely to pick up calls from a private number. Counsellors will monitor and encourage correct use of NRT and work with clients to address barriers to its use.

Safety and product re-fill calls will provide an opportunity to assess adherence with the allocated study products. Self-reported use of the NRT and Quitline will also be gathered during the 3-month and 9-month follow-up surveys. Participants do not need to utilise all NRT or Quitline for the entire study period to be able to participate.

Control group

Active

Outcomes

Primary outcome [1]

Self-reported 7 months continuous abstinence from tobacco smoking
This will be measured utilising a number of items specifically created for this study. Items include: a) duration since quitting smoking; b) occasions of smoking since quitting; c) occasions of smoking for a week; d) duration to week long relapse. These items together will inform whether individuals meet self-reported 7-month continuous abstinence from tobacco smoking.

Timepoint [1]

9 months after inpatient withdrawal unit discharge

Secondary outcome [1]

Biochemically verified 7 month continuous abstinence from tobacco smoking
A participant reporting that they have quit smoking for the last 7 months and have smoked on five or less than 5 occasions or not at all will be asked to complete a bedfront smokelyzer breath test to measure expired carbon monoxide (CO). A participant with a CO level less than 8ppm will be considered abstinent. The bedfont smokelyzer breath test will be conducted by a trained research assistant.

Timepoint [1]

9 months after inpatient withdrawal unit discharge

Secondary outcome [2]

30 day point prevalence abstinence
A composite measure will be used. The first item will ask participants "Have you smoked at all, even a puff, in the last 30 days?" with response options a) yes, b) no. A second measure will ask participants "How many cigarettes have you smoked in the last 30 days?" with response options a) less than 1 or just a puff; b) 1-5; c) 6-10; d) 11-20; More than 20. Both measures will be self-reported 30 day point prevalence abstinence and refers to the 30 days preceding the follow-up period in which the question is asked.

Timepoint [2]