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The SQuARe Trial: Staying Quit After Release from Prison

Efficacy of a pre-release brief behavioural intervention on extending prisoners' smoking abstinence following release from smoke-free prisons in Victoria

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000072213
Acronym
SQuARe (Staying QUit After RElease from prison)
Enrollment
200
Registered
2018-01-17
Start date
2018-06-18
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

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.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026