PubMed:23471101 JSONTXT

{"project":"PCI_RCT","denotations":[{"id":"T1","span":{"begin":245,"end":253},"obj":"CI"},{"id":"T10","span":{"begin":601,"end":608},"obj":"CI"},{"id":"T11","span":{"begin":78,"end":85},"obj":"CI"},{"id":"T12","span":{"begin":1096,"end":1103},"obj":"CI"},{"id":"T13","span":{"begin":1068,"end":1075},"obj":"CI"},{"id":"T14","span":{"begin":1182,"end":1189},"obj":"CI"},{"id":"T15","span":{"begin":1413,"end":1420},"obj":"CI"},{"id":"T2","span":{"begin":0,"end":8},"obj":"CI"},{"id":"T3","span":{"begin":12,"end":28},"obj":"CI"},{"id":"T4","span":{"begin":142,"end":158},"obj":"CI"},{"id":"T5","span":{"begin":584,"end":591},"obj":"CI"},{"id":"T6","span":{"begin":362,"end":369},"obj":"CI"},{"id":"T7","span":{"begin":1574,"end":1590},"obj":"CI"},{"id":"T8","span":{"begin":259,"end":307},"obj":"CI"}],"text":"Niccine®, a nicotine vaccine, for relapse prevention: a phase II, randomized, placebo-controlled, multicenter clinical trial.\nINTRODUCTION: A nicotine vaccine could prevent relapse to smoking by hindering blood nicotine from reaching the brain. Niccine® is a nicotine hapten tetanus-toxoid conjugate vaccine. The present study evaluated the clinical efficacy of Niccine for tobacco smoking relapse prevention.\nMETHODS: Cigarette smokers (n = 355) aged 25-50 years were enrolled in a randomized, double-blind, parallel group 1-year trial encompassing 16 visits and 16 telephone calls. Niccine 40 μg or placebo was administered on Days 0, 28, 56, 90, 150, and 210. Between Days 56-98, subjects were treated with varenicline to aid cessation, targeted for Day 70. Only individuals abstinent between Days 90-98 (n = 265) were allowed to continue to 1 year (n = 219). Relapse to smoking was defined as \u003e5 cigarettes within 7 days or since the last contact, or smoking on \u003e5 occasions within 7 days or since the last contact.\nRESULTS: At 1 year, nonrelapse was 43.3% in the Niccine versus 51.1% in the placebo groups (difference = -7.9%; 95% CI = -20.6% to 4.9%). There was no benefit of Niccine on smoking status at 6 or 9 months, exhaled carbon monoxide levels, time to relapse, abstinence, withdrawal symptoms, or smoking reinforcement. Nicotine antibody levels increased (mean = 1.34 μg/ml; SD = 2.84 μg/ml) in the Niccine group, but were not related to relapse. Adverse events except hypersensitivity and compensatory smoking did not differ between groups.\nCONCLUSIONS: This nicotine vaccine appeared well tolerated but did not influence trajectories of relapse possibly because of insufficient antibody levels or lack of efficacy of the vaccine concept for relapse prevention."}