Study Protocol: A Randomised Controlled Trial of Nortriptyline Added to a Smoking Cessation Intervention Conducted among Prisoners

Background: Prisoners endure some of the worst health outcomes of any population group in the community. Smoking rates among prisoners remain high despite a significant reduction in smoking rates among the general public. This protocol describes a study in which we will assess the effectiveness of a smoking cessation intervention conducted among male prisoners.
Methods/Design: 425 male smoking prisoners will be recruited. After completion of a baseline assessment, participants will receive a multi-component smoking cessation intervention comprising two half hour individual sessions of cognitive behavioural therapy and nicotine replacement therapy with either active Nortriptyline or placebo. Blinded follow up assessments will be conducted at 3, 6 and 12 months.
Discussion: This study will provide data on the efficacy of Nortriptyline as a smoking cessation aid for male prisoners in combination with a multi-component smoking cessation intervention. No other smoking cessation randomised controlled trials on male prisoners has been published.
Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: #12606000229572. http://www.anzctr.org.au/trial_view.aspx?ID=1329