A multi-component intervention for smoking cessation among Australian male prison inmates

INTERVENTION: 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. CONDITION: Tobacco Addiction PRIMARY OUTCOME: Continued abstinence. Continuous abstinence is defined as abstinence between quit day and a specified follow‐up period 3 months, 6 months and 12 months. 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. SECONDARY OUTCOME: Anxiety & depression measured by the PRIME and Kessler 10 (K‐10). Physical and mental wellness measured by the Short Form 12 (SF‐12). 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.