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Trial registered on ANZCTR


Registration number
ACTRN12618000072213
Ethics application status
Approved
Date submitted
27/06/2017
Date registered
17/01/2018
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The SQuARe Trial: Staying Quit After Release from Prison
Scientific title
Efficacy of a pre-release brief behavioural intervention on extending prisoners' smoking abstinence following release from smoke-free prisons in Victoria
Secondary ID [1] 292290 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SQuARe (Staying QUit After RElease from prison)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking 303810 0
Condition category
Condition code
Public Health 303177 303177 0 0
Health promotion/education
Mental Health 304949 304949 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive:
1. Brief counselling: Case workers will deliver one-on-one, personalised, brief (<10 minutes) cognitive-behavioural support at three time points: 1) between baseline and release from prison; 2) on the day of release from prison; and 3) two weeks after release from prison.
Core tasks will include building participants' intrinsic motivation to stay quit post release, and helping them plan how to cope with cravings by identifying alternatives to replace the functions that smoking served (e.g., stress management, rewards) and strategies for dealing with friends/family who smoke, and encouraging use of evidence-based cessation assistance. The intervention will be tailored to address particular barriers to maintaining abstinence for people recently released from prison, such as smoking's association with freedom, heightened stress and anxiety levels upon and soon after release, subcultural norms related to smoking, and high levels of mental disorder and alcohol and other drug use. Normalisation of 'slip ups' and support to quit again post-relapse will be offered.

2. Relapse prevention calls from Quitline. Participants will be invited to provide a contact telephone number for a Quitline counsellor to contact them on days 1, 3, 7, 14 and 28 post release. These phone calls are anticipated to be approximately 10 minutes in duration.

3. Short-acting NRT: Nine days' supply of nicotine mouth spray will be provided to participants by an ACSO case worker on the day of release from prison, and again at a two-week follow-up contact. Each nicotine spray has 150 doses per spray pump, at 1mg per dose. Participants will be advised to use 1-2 sprays in their mouth whenever experiencing a cigarette craving, but no more than 2 sprays at once. Participants will be advised not to use more than 64 sprays within a 24 hour period, which is equal to 4 sprays per hour for 16 hours. ACSO staff will ask about nicotine spray at each follow-up, and will check for correct use, as will Quitline staff during phone calls.

The following instructions will be provided to participants, verbally and in written format: “The mouth spray has a child proof button. Follow the instructions on the packet so the green pump pops up out of the top of the dispenser. If the spray is being used for the first time or it has not been used for several days, the spray should be primed. Priming involves pointing the spray away from you and depressing the dispenser with the index finger several times until a fine mist appears. This ensures the correct dosage is dispensed.
Hold the pump close to your mouth and point the spray nozzle towards the side of your cheek or under your tongue, being sure to avoid the lips. Press down once. If cravings do not start to ease within a few minutes, use a second spray. Do not use more than 64 sprays within a 24 hour period, which is equal to 4 sprays per hour for 16 hours. Do not spray directly into the throat, directly onto the tongue or inhale while spraying. Do not breathe in while spraying to avoid getting it on your throat – this can cause hiccups or a burning feeling in the throat. Do not swallow for a few seconds after spraying for the best results – this is so the nicotine can be absorbed through the lining of the mouth. You should avoid eating and drinking 15 minutes before, and during, use of the mouth spray (except for water). Acidic foods or drinks, such as orange juice, coffee, beer and soft drink, interfere with the amount of nicotine passing through the lining of your mouth from the spray. If you get spray in your eye, rinse it immediately using lots of water. If you slip up and have a puff or a cigarette, don’t let it lead you back to full-time smoking. It is safe to keep using the mouth spray and re-commit to stopping smoking. If you go back to regular smoking you can also use the nicotine mouth spray to cut down the number of cigarettes you smoke before trying to stop smoking.”

4. Referral to primary care: Participants will be referred to bulk-billing General Practitioners in order to access PBS-subsidised nicotine patches. Case workers will identify a suitable bulk-billing primary care practice for each participant, and encourage the participant to make an appointment with a GP to discuss smoking cessation support. ReConnect staff will make a referral to primary care at the pre-release appointment and will follow this up with participants at subsequent appointments. Connecting prisoners with health care is a routine part of their service. For those who relapse to smoking during follow-up, combination therapy (where patches are combined with a short-acting form of NRT such as spray) is recommended best practice for nicotine-dependent smokers. Participants' visit to a GP clinic to access heavily PBS subsidised patches ($6.10 for health care card holders*) in combination with the provided nicotine spray will ensure that combination therapy is available to each participant soon after release from prison.
Intervention code [1] 298463 0
Treatment: Devices
Intervention code [2] 298464 0
Behaviour
Intervention code [3] 299690 0
Lifestyle
Comparator / control treatment
Participants will receive usual care. If they request smoking cessation support (which is rare), this will be provided by ReConnect staff.Participants in both arms of the trial will be provided with a postcard that illustrates what they could buy with the money saved by not smoking following release, and the Quitline phone number, as part of the transition information routinely provided by ReConnect staff. Participants will be free to use any form of smoking cessation assistance they choose during the study period, although we expect that few in the control arm will do so as smokers in general are reluctant to seek cessation support.
Control group
Active

Outcomes
Primary outcome [1] 302565 0
Smoking relapse, defined as the combination of (a) self-report of not smoking for any 7 consecutive days since release from prison, (b) self-reported 7-day abstinence at follow-up, and (c) biochemically verified (carbon monoxide breath test) point prevalence abstinence at follow-up, measured at 1 and 3 months following release from prison
Timepoint [1] 302565 0
One month (primary time point) and three months following release from prison
Primary outcome [2] 304211 0
Among those reporting relapse (defined as smoking for 7 or more consecutive days), recovery from relapse, defined as the combination of (a) 7-day period prevalence abstinence at follow-up, and (b) biochemical validation (carbon monoxide breath t of point prevalence abstinence at follow-up,measured at 1 and 3 months following release from prison
Timepoint [2] 304211 0
One month (primary time point) and three months following release from prison
Secondary outcome [1] 336376 0
Utilisation of abstinence supports including Quitline, GPs, or nicotine replacement therapy, assessed verbally and recorded in a spreadsheet, assessed at one and three months following release from prison.
Timepoint [1] 336376 0
One month and three months following release from prison

Eligibility
Key inclusion criteria
Eligible participants will be: (1) clients of ACSO's ReConnect program in participating regions, (2) adults (aged greater than or equal to 18 years), (3) within six weeks of expected release from participating prisons in Victoria, (4) daily tobacco smokers prior to prison entry, and (5) able to provide informed, written consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) People aged under 18 years of age, 2) Due for release in more than six weeks, 3) Not daily smokers prior to prison entry 4) Not able to provide informed, written content due to intellectual disability.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random assignment of participants will be done using permuted block randomisation.

Within each block, an equal number of intervention and control conditions will be
assigned. Use of random permuted blocks ensures balance during assignment and helps to prevent participants from guessing which condition they have been assigned to. At this stage, the number of prisoners who intend to remain abstinent from smoking after release is unknown. To account for the unlikely possibility that all participants intend to remain abstinent, the list needs to reflect double the intended sample size.
The list is also stratified by intention to quit. Literature shows that those prisoners who have an intention to quit are more likely to remain abstinent post-release, making it important to have equal numbers of those who do and do not intend to remain abstinent from smoking post-release in both the intervention and control groups. Thus, at the end of the baseline assessment, the researcher will ask the participant if they intend to stay quit from tobacco smoking post-release or not. Depending on their answer, the researcher will open the next concealed envelope and they will be automatically and randomly assigned to either the intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary cessation outcomes will be analysed on an intention-to-treat basis both including those lost to follow-up (coded as treatment failures) and including only cases with follow-up data.
Bivariate analyses (e.g., chi square tests) will test for differences between treatment groups on smoking cessation outcomes. Generalised linear mixed models (logistic regression for dichotomous outcomes and linear regression for continuous outcomes) will test whether differences between treatment groups persist after adjusting for correlation between repeated measures and controlling for other identified predictors of quit success. In addition, we will explore a possible dose-response relationship between the amount of cessation support received (behavioural and/or pharmacological) and abstinence.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296833 0
Government body
Name [1] 296833 0
Victoria Health
Country [1] 296833 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Mental Health, Melbourne School of Population and Global Health, University of
Melbourne
Level 4, 207 Bouverie Street
Carlton, Victoria
3010
Country
Australia
Secondary sponsor category [1] 295826 0
Other
Name [1] 295826 0
Quit Victoria
Address [1] 295826 0
615 St Kilda Rd, Melbourne Victoria 3004 Australia
Country [1] 295826 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298065 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 298065 0
Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
VIC 3010
Ethics committee country [1] 298065 0
Australia
Date submitted for ethics approval [1] 298065 0
08/01/2018
Approval date [1] 298065 0
Ethics approval number [1] 298065 0
Ethics committee name [2] 298066 0
Corrections Victoria Research Committee
Ethics committee address [2] 298066 0
Level 22
121 Exhibition Street
Melbourne, VIC
3000
Ethics committee country [2] 298066 0
Australia
Date submitted for ethics approval [2] 298066 0
20/10/2017
Approval date [2] 298066 0
25/10/2017
Ethics approval number [2] 298066 0
CD/17/607402
Ethics committee name [3] 299163 0
Justice Health Research Ethics Committee
Ethics committee address [3] 299163 0
Department of Justice and Regulation
121 Exhibition St,
Melbourne VIC
3000
Ethics committee country [3] 299163 0
Australia
Date submitted for ethics approval [3] 299163 0
26/10/2017
Approval date [3] 299163 0
Ethics approval number [3] 299163 0

Summary
Brief summary
Smoking rates are extremely high among people cycling through Australian prisons, estimated at 74% of prison entrants in 2015. Indigenous Australians and people with mental illness are markedly over-represented in prisons and experience increased smoking-related health inequalities compared to both their community counterparts and non-Indigenous prisoners. Around one in two people entering prison in Australia who smoke expresses a desire to quit smoking. As a result, correctional authorities in Australia and elsewhere are implementing smoke-free policies that prohibit tobacco smoking on prison grounds for prisoners and prison staff. On 1 July 2015, a total smoking ban was introduced in all Victorian prisons.

This randomised controlled trial (RCT) aims to test the effect of an intervention that promotes tobacco abstinence after release from prison among previously-smoking adults subjected to enforced abstinence in smoke-free prisons in Victoria. 200 participants will be recruited in prison (within 6 weeks of release) and will complete a baseline survey. Following baseline assessment, participants will be randomised 1:1 to intervention or usual care; randomisation will be stratified by intention to quit. Australian Community Support Organisation (ACSO) case workers will deliver a brief intervention to intervention group participants at three time points: prior to release, on the day of release and 2 weeks post-release, supplemented by a telephone calls from Quitline in the first 28 days post-release. Participants will receive a nine-day supply of nicotine spray on the day of release and again during the 2-week post-release intervention contact. ACSO staff will encourage participants to see a GP to discuss smoking cessation and access PBS-subsidised NRT patches if appropriate.

The aims of this study are to evaluate the effects of a brief smoking cessation intervention on:
1. Prevention of smoking relapse, defined as the combination of (a) self-report of not smoking for any 7 consecutive days since release from prison, (b) self-reported 7-day abstinence at follow-up, and (c) biochemically verified (carbon monoxide breath test) point prevalence abstinence at follow-up, measured at 1 and 3 months following release from prison
2. Among those reporting relapse (defined as smoking for 7 or more consecutive days), recovery from relapse, defined as the combination of (a) 7-day period prevalence abstinence at follow-up, and (b) biochemical validation (carbon monoxide breath t of point prevalence abstinence at follow-up,measured at 1 and 3 months following release from prison
3. Utilisation of abstinence supports in the first three months after release from prison: Quitline, GPs, nicotine replacement therapy (NRT), measured at 1 and 3 months following release from prison
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75878 0
Prof Stuart Kinner
Address 75878 0
Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
Carlton, Victoria 3010
Country 75878 0
Australia
Phone 75878 0
+61 3 9035 7598
Fax 75878 0
Email 75878 0
skinner@unimelb.edu.au
Contact person for public queries
Name 75879 0
Stuart Kinner
Address 75879 0
Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
Carlton, Victoria 3010
Country 75879 0
Australia
Phone 75879 0
+61 3 9035 7598
Fax 75879 0
Email 75879 0
skinner@unimelb.edu.au
Contact person for scientific queries
Name 75880 0
Stuart Kinner
Address 75880 0
Melbourne School of Population and Global Health
Level 4, 207 Bouverie Street
Carlton, Victoria 3010
Country 75880 0
Australia
Phone 75880 0
+61 3 9035 7598
Fax 75880 0
Email 75880 0
skinner@unimelb.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStaying Quit after Release (SQuARe) trial protocol: A randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia.2019https://dx.doi.org/10.1136/bmjopen-2018-027307
N.B. These documents automatically identified may not have been verified by the study sponsor.