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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]

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

Condition category

Condition code

Mental Health

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]

Prevention

Comparator / control treatment

Group 2 will receive placebo NOR

Control group

Placebo

Outcomes

Primary outcome [1]

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]

At 12 months. Also reported for the 3 and 6 month follow-ups.

Primary outcome [2]

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]

At 12 months. Also reported for the 3 and 6 month follow-ups.

Secondary outcome [1]

Anxiety & depression measured by the PRIME and Kessler 10 (K-10).

Timepoint [1]

Initial screening.Also reported for 3month, 6 month and 12 month follow ups.

Secondary outcome [2]

Physical and mental wellness measured by the Short Form 12 (SF-12).

Timepoint [2]

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

Sex

Males

Can healthy volunteers participate?

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

1/07/2006

Actual

1/08/2006

Date of last participant enrolment

Anticipated

30/09/2009

Actual

30/09/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

426

Accrual to date

Final

425

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

NHMRC
GPO Box 9848
Canberra ACT 2601

Country [1]

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]

Government body

Name [1]

Justice Health NSW

Address [1]

PO Box 150 Matraville NSW 2306

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW HREC

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

22/03/2005

Approval date [1]

22/03/2005

Ethics approval number [1]

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

Prof Robyn Richmond

Address

SPHCM, UNSW
Kensington, 2052

Country

Australia

Phone

+61 2 9385 2512

Fax

R.Richmond@unsw.edu.au

Contact person for public queries

Name

Fran Hyslop

Address

SPHCM, UNSW
Kensington, 2052

Country

Australia

Phone

+61 2 9385 1746

Fax

+61 2 9313 6185

f.hyslop@unsw.edu.au

Contact person for scientific queries

Name

Professor Robyn Richmond

Address

School of Public Health and Community Medicine University of New South Wales UNSW NSW 2052

Country

Australia

Phone

+61 2 9385 2512

Fax

+61 2 93136185

r.richmond@unsw.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

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