It was an FDA mandated study to review the neuropsychiatric safety of 4 treatment arms Varenicline vs Bupropion vs Nicotine Patch vs Placebo. There were 2 patient groups those with an approved and stable mental health history and those without. The patients followed the standard smoking cessation treatment algorithms for each product under our intense monitoring.
We were responsible for the Ethics Application and Management , medsafe/SCOTT review including application for approval of the study nicotine patch. We employed both a Psychiatrist and a clinical Psychologist for the neuropsychiatric screening and subsequent safety testing.
The recruitment of the 8000 required participants was 4000 in the US with the rest broken down to the rest of the world. As the only site NZ LCT was allocate an entire country allocation of 75 patients. We managed to meet this target earlier than planned and then were offered an extension.
Lakeland Clinical Trials recruited the largest cohort of patients outside of the USA.
Achieved “INSPIRE Status” - as a centre of Excellence for Pfizer - we are the only site in NZ with this award.