NicoNovum Evaluation of Withdrawal Relief Study Part 2

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2007
INTERVENTION: Niconovum nicotine mouthspray (1mg/spray ‐ 3 spray dose). Mode of administration: Spray between cheek and gum. Niconovum nicotine lozenge (2.5mg). Mode of administration: dissolve in mouth ‐ do not chew. This trial has a crossover design with each product used for 12 hours, with washout period of three days. Total trial time (due to staggered design) ‐ 4 weeks. CONDITION: Smokers PRIMARY OUTCOME: Change in composite craving score over time. SECONDARY OUTCOME: Change in individual withdrawal symptoms over time. Comparison of plasma nicotine concentrations and relationship with withdrawal relief. Comparison of side effects Comparison of subjective ratings of product Helpfulness and satisfaction INCLUSION CRITERIA: INCLUSION CRITERIA:Smoke =15 cigarettes per day for the last year Smoke within 30 minutes of wakingSelf‐report being in good health with verification by medical history. Be able to attend the study site for 4 weeks on the same day of the week. Be able to read and write English. Participants are capable of giving informed consent.
Epistemonikos ID: e6506de8ad96c20f008eb4eba87869265b45ae3d
First added on: Aug 21, 2024