Participant flow

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking · Source last updated 2016-03-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.

   id

   FG000

   title

   Nicotine Patch

2. description

   Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

   id

   FG001

   title

   Nicotine Lozenge

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         139

      2. group Id

         FG001

         num Subjects

         154

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         321

      2. group Id

         FG001

         num Subjects

         321

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         167

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         139

      2. group Id

         FG001

         num Subjects

         154

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

1299 individuals were screened for this trial over 4 years; 454 individuals were ineligible, 194 refused enrollment, and 651 were randomized. Nine individuals either withdrew from the study prior to treatment or were found to be ineligible after randomization and were removed from the intent-to-treat sample. The final ITT sample was 642 (321/arm).

recruitment Details

Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health.

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Preserved source evidence · Not medical advice