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Trial registered on ANZCTR


Registration number
ACTRN12606000229572
Ethics application status
Approved
Date submitted
5/06/2006
Date registered
6/06/2006
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-component intervention for smoking cessation among Australian male prison inmates
Scientific title
A randomised trial of nortriptyline, nicotine replacement therapy,and brief cognitive behavioural therapy (CBT) vs. placebo, nicotine replacement therapy, and brief cognitive behavioural therapy for smoking cessation among prison inmates.
Secondary ID [1] 266 0
University of New South Wales: 14047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Addiction 1207 0
Condition category
Condition code
Mental Health 1292 1292 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 will receive active Nortryptline (NOR) and Group 2 will receive placebo NOR. Both groups will receive brief CBT, active nicotine patch, a prison stress package and access to the Quitline. The stop smoking date is set for the third week following the commencement of (Nortryptline or placebo) treatment. This date coincides with commencing NRT) Active Treatment (Nortryptline) Non Active Treatment ( Placebo) dosage is 25mg/d (1 tablet) for 3 days and then 50mg/d (2 tablets) for 4 days. Then 75mg ( 3 tablets ) for 10wks .The is dosage is tapered to 50mg/d (2 tablets) for 4 days and then 25mg/d (1 tablet) for 3 days.2) Brief CBT is held week 3 and week 4-6. 3) Stress package: During the second brief CBT session all inmates will be provided with a prison specific ‘coping with change’ package in the event that they are transferred to a different correctional facility. 4) Nicotine Transdermal Patch(NRT) : Beginning in week 3, a 24-hour or 16hr transdermal nicotine patch will be distributed daily to all subjects. Over the 10-week course of patch therapy, a structured tapering system will be employed: 21mg of nicotine per day for the first 6 weeks, followed by 14mg/d over the next 2 weeks and 7mg/d in the final 2 weeks of therapy. 5)Quitline: All inmates will receive information about, and the number of the Quitline.
Intervention code [1] 1081 0
Prevention
Comparator / control treatment
Group 2 will receive placebo NOR
Control group
Placebo

Outcomes
Primary outcome [1] 1760 0
Point prevalence abstinence. Point prevalence is defined as the proportion of subjects who have not smoked at all during a particular time period and allows for the inclusion a grace period.
Timepoint [1] 1760 0
At 12 months. Also reported for the 3 and 6 month follow-ups.
Primary outcome [2] 1761 0
Continued abstinence. Continuous abstinence is defined as abstinence between quit day and a specified follow-up period 3 months, 6 months and 12 months.
Timepoint [2] 1761 0
At 12 months. Also reported for the 3 and 6 month follow-ups.
Secondary outcome [1] 3110 0
Anxiety & depression measured by the PRIME and Kessler 10 (K-10).
Timepoint [1] 3110 0
Initial screening.Also reported for 3month, 6 month and 12 month follow ups.
Secondary outcome [2] 3111 0
Physical and mental wellness measured by the Short Form 12 (SF-12).
Timepoint [2] 3111 0
Short Form 12 ( SF-12) Initial screening.Also reported for 3month, 6 month and 12 month follow ups.

Eligibility
Key inclusion criteria
Has been incarcerated for >1 month with >6 months of the current sentence remaining; English speaker; scores >5 on the Fagerström Test for Nicotine Dependence (indicates moderate to high nicotine dependence); readiness to quit.
Minimum age
18 Years
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
current significant cardiovascular disease (e.g. evidence of conduction defects on ECG); Current major depressive disorder; bipolar disorder; current antidepressant or antipsychotic medication; threats of suicide or repeated deliberate self harm; current psychotic disorder; use of a monoamine oxidase inhibitors within two weeks; known allergies to the study drugs; life threatening illness.

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)
Placebo or active allocated from central pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised block design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1418 0
Government body
Name [1] 1418 0
National Health and Medical Research Council
Address [1] 1418 0
NHMRC
GPO Box 9848
Canberra ACT 2601
Country [1] 1418 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Public Health and Community Medicine
Level 3, Samuels Building
University of New South Wales NSW 2052
Country
Australia
Secondary sponsor category [1] 1244 0
Government body
Name [1] 1244 0
Justice Health NSW
Address [1] 1244 0
PO Box 150 Matraville NSW 2306
Country [1] 1244 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294644 0
UNSW HREC
Ethics committee address [1] 294644 0
Ethics committee country [1] 294644 0
Date submitted for ethics approval [1] 294644 0
22/03/2005
Approval date [1] 294644 0
22/03/2005
Ethics approval number [1] 294644 0
HREC05044

Summary
Brief summary
.Aim To evaluate the efficacy of nortriptyline (NOR) added to a multi-component smoking cessation intervention, which included cognitive–behavioural therapy (CBT) and provision of nicotine replacement therapy (NRT). Design Randomized controlled trial (RCT) comparing two study groups with blinded follow-up at 3, 6 and 12 months.
Both groups received amulti-component smoking cessation intervention comprising two half-hour individual sessions of CBT and NRT with either active NOR or placebo. Setting Prisons in New South Wales (17) and Queensland (one), Australia. Participants A total of 425 male prisoners met inclusion criteria and were allocated to either treatment (n = 206) or control group (n = 219). Measurements Primary end-points at 3, 6 and 12 months were continuous abstinence, point prevalence abstinence and reporting a 50% reduction in smoking. Smoking status was confirmed by expired carbon monoxide, using a cut-point of 10 parts per million. Findings Participants’ demographics and baseline tobacco usewere similar in treatment and control groups. Based on an intention-to-treat analysis, continuous
abstinence between the treatment and control groups was not significantly different at 3 months (23.8 versus 16.4%), 6 months (17.5 versus 12.3%) and 12 months (11.7 versus 11.9%). Conclusion Adding nortriptyline to a smoking cessation treatment package consisting of behavioural support and nicotine replacement therapy does not appear to improve long-term abstinence rates in male prisoners.
Trial website
Trial related presentations / publications
1. Belcher J, Butler T, Richmond R, Wodak A, Wilhelm K. Smoking and its correlates in an Australian prisoner population. Drug and Alcohol Review, 2006; 25: 343-48.
2. Richmond RL. Butler T. Belcher JM. Wodak A. Wilhelm KA. Baxter E. Promoting smoking cessation among prisoners: feasibility of a multi-component intervention. Australian and New Zealand Journal of Public Health, 2006; 30(5):474-8.
3. Butler T, Richmond R, Belcher J, Wilhelm K, Wodak A. Should smoking be banned in prisons? Tobacco Control, 2007; 16:291-293.
4. Richmond R, Butler, T, Wilhelm K, Wodak A, Cunningham M, Anderson I. Factors influencing smoking among prison inmates: focus group study. Tobacco Control, 2009; 18(3): 176-182.
5. Richmond R, Indig D, Butler T, Wilhelm K, Wodak A. Cardiovascular risk among Aboriginal and non-Aboriginal smoking male prisoners: Inequalities compared to the wider community. BMC Public Health 2011, 11:783.
6. Richmond R, Butler T, Indig D, Wilhelm K, Archer V, Wodak A. The Challenges of Reducing Tobacco Use among Prisoners. "Tackling tobacco use in socially disadvantaged groups: A time for action" Drug and Alcohol Review Special Edition, 2012; 31(5):625-30.
7. Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. Smoking characteristics of Aboriginal and non-Aboriginal prisoners in Australia. Journal of Addiction, 2013; 2013:516342.
8. Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A Randomised Controlled Trial of a Smoking Cessation Intervention Conducted among Prisoners. Addiction, 2013; 108(5): 966-974.
9. Richmond R, Butler T, Wilhelm K, Indig D, Archer V, Wodak A. Study protocol: a randomised controlled trial of a smoking cessation intervention conducted among prisoners. British Journal of Medicine and Medical Research, 2013; 3(4):1607-1620.
10. Indig D, Wodak A, Richmond R, Butler T, Archer V, Wilhelm K. Heroin use impairs smoking cessation among Australian prisoners BMC Public Health 2013;13:1200.

1. Richmond R, Indig D, Wilhelm K, Butler T, Wodak A Cardiovascular risk among Aboriginal and non-Aboriginal smoking male prisoners: Inequalities compared to the wider community. UNSW School of Public Health and Community Medicine 5th Annual Research Symposium; Oct, 2013
2. Richmond R, Wilhelm K, Indig D, Butler T, Archer V, Wodak A. Improving Inequalities in Health: A Randomised Controlled Trial to Reduce Tobacco Use among Male Prisoners. National Heart Foundation Conference, Adelaide. May 2013
3. Richmond R, Wilhelm K, Indig D, Wodak A, Archer V, Butler T. Art Assisting Smoking Prisoners to Quit. 3rd Annual Art of Good Health and Wellbeing International Arts and Health Conference, Canberra, November 2011.
4. Richmond R, Wilhelm K, Indig D, Wodak A, Archer V, Butler T. Tackling tobacco in socially disadvantaged groups: interventions, programs, opportunities and progress. Oceania Tobacco Control Conference. Brisbane, October, 2011.
5. Richmond R, Wilhelm K, Indig D, Wodak A, Archer V, Butler T. Cardiovascular risk among smoking male prisoners: Inequalities compared to the wider community. Poster presentation at Society for Nicotine and Tobacco Research Europe Meeting; Antalya, Turkey; September 2011.
6. Richmond R. Prisons presentation. Third Annual Symposium on "Advances in Public Health and Health Services Research at UNSW". Sydney, August, 2011.
7. Richmond R, Indig D, Archer V, Butler T, Wodak A, Wilhelm K. Cardiovascular risk factors among tobacco smoking prison inmates. Asia Pacific Conference on Tobacco or Health. Sydney, October 2010
8. Robyn Richmond, Devon Indig, Vicki Archer, Tony Butler, Alex Wodak, Kay Wilhelm, Cardiovascular risk factors among prison inmates Public Health Association of Australia, Justice Health in Australia, Melbourne, April 2009
9. Richmond et al. Reducing Smoking among male prison inmates. School of Public Health and Community Medicine, University of New South Wales, 2008.
Public notes

Contacts
Principal investigator
Name 36283 0
Prof Robyn Richmond
Address 36283 0
SPHCM, UNSW
Kensington, 2052
Country 36283 0
Australia
Phone 36283 0
+61 2 9385 2512
Fax 36283 0
Email 36283 0
R.Richmond@unsw.edu.au
Contact person for public queries
Name 10270 0
Mrs Fran Hyslop
Address 10270 0
SPHCM, UNSW
Kensington, 2052
Country 10270 0
Australia
Phone 10270 0
+61 2 9385 1746
Fax 10270 0
+61 2 9313 6185
Email 10270 0
f.hyslop@unsw.edu.au
Contact person for scientific queries
Name 1198 0
Prof Professor Robyn Richmond
Address 1198 0
School of Public Health and Community Medicine University of New South Wales UNSW NSW 2052
Country 1198 0
Australia
Phone 1198 0
+61 2 9385 2512
Fax 1198 0
+61 2 93136185
Email 1198 0
r.richmond@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary