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A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers
Author(s) -
Glover Elbert D.,
Laflin Molly T.,
Schuh Kory J.,
Schuh Leslie M.,
Nides Mitch,
Christen Arden G.,
Glover Penny N.,
Strnad Julia V.
Publication year - 2007
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/j.1360-0443.2007.01763.x
Subject(s) - mecamylamine , nicotine , medicine , abstinence , anesthesia , smoking cessation , transdermal patch , randomized controlled trial , nicotine replacement therapy , population , nicotine patch , pharmacology , transdermal , antagonist , placebo , psychiatry , receptor , alternative medicine , environmental health , pathology
Aims To determine the efficacy and safety of nicotine transdermal therapy co‐administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine). Design Multi‐center ( n = 4), double‐blind, randomized, parallel group, repeat‐dose study. Setting Clinical laboratory. Participants A total of 540 subjects were enrolled into the study—135 from each of four sites; 180 patients in each of three treatment arms. Intervention Treatment was administered for the first 6 weeks of the 8‐week study. Patients were instructed to continue smoking for the first 2 weeks of treatment. Measurements The primary efficacy parameter was 4‐week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million. Findings Analysis of the 4‐week continuous abstinence for the intent‐to‐treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non‐significant group differences (29%, 27%, 26%). Conclusion If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.