A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 2b Trial of Cytisinicline in Adult Smokers

ORCA-12018-11-06T22:19:33+00:00
ORCA-1

This Phase 2b trial is being conducted in the US to assess various dosing schedules of cytisinicline in approximately 250 people. It will evaluate efficacy based on the overall reduction in the number of cigarettes smoked during the various study treatment doses and schedules. It will also compare compliance and safety profiles, compared to the respective placebo arms. Results from this study will be used for defining future cytisinicline development.

Study Design

This will be a six-arm, multi-center, double-blind, randomized, placebo-controlled, Phase 2b study conducted in the US. The study will be double-blinded to dose but not to the administration schedule. Subjects must provide a quit date 5-7 days from randomization. Study treatment must start the day after randomization such that study treatment is initiated prior to the quit date.

Subjects must meet all inclusion and exclusion criteria. Subjects will be stratified at randomization by BMI class (18.5 to <25 kg/m2; 25 to <30 kg/m2; 30 to <35 kg/m2). A total of approximately 250 subjects will be randomized 2:2:1:2:2:1 in a blinded manner to either Arm A or Arm B, vs Arm C or Arm D or Arm E vs Arm F.

ORCA-1 Program Study Design. Click image to enlarge.

ORCA-1 Trial Locations

ORCA-1 is being conducted at the following locations in the US.

AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY DC

Central Kentucky Research
www.ckraresearch.com

Volunteer Research Group
www.volresearch.com

Center for Pharmaceutical Research
http://www.cprkc.com

FutureSearch Trials of Dallas
www.fstrials.com

Coastal Carolina Research Center in North Charleston
www.coastalcarolinaresearch.com

Rochester Clinical Research, Inc.
www.rcrclinical.com

Clinical Research Consortium
www.crctrials.com