None listed
Conditions
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 _x0002_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.
Interventions
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
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed