Acute effects of Advance: a potential reduced exposure product for smokers.

OBJECTIVE: To examine the acute effects of Advance, a potential reduced exposure product (PREP) for smokers marketed as a means to reduce exposure to toxic gases and tobacco specific nitrosamines. DESIGN, SETTING, PARTICIPANTS: Latin square ordered, three condition, laboratory based, crossover design with 20 smokers of light or ultra-light cigarettes (15 or more cigarettes/day). In each 2.5 hour condition, participants completed an 8-puff smoking bout from their own brand, Advance, or an unlit cigarette (that is, sham smoking) every 30 minutes for a total of four bouts. MAIN OUTCOME MEASURES: Subject rated measures of tobacco/nicotine withdrawal; carbon monoxide (CO), and heart rate; plasma nicotine concentrations. RESULTS: Relative to own brand, Advance produced similar withdrawal suppression and heart rate increase, lower CO boost, and higher plasma nicotine concentrations. CONCLUSIONS: PREPs for smokers need to be evaluated using a comprehensive strategy that includes empirical examination of acute and long term effects. Adequate withdrawal suppression and potentially lower concentrations of CO associated with Advance use are positive factors, although higher nicotine concentrations do not constitute "reduced exposure". Overall, longer exposure periods are necessary to determine carcinogen delivery. PREP evaluation is complex and should be completed objectively.

Withdrawal-suppressing effects of a novel smoking system: comparison with own brand, not own brand, and de-nicotinized cigarettes.

Tobacco smoking is associated with many health risks, all of which are decreased by smoking cessation. Tobacco companies are marketing novel products (e.g., Phillip Morris' Accord, R.J. Reynolds' Eclipse) intended to reduce these risks. Evaluation of these products is necessary to determine if they increase, decrease, or fail to change smoking's health risks. This study examines the acute effects of the Accord system on cigarette smokers; the study extends a previous preliminary evaluation by controlling for the system's eight-puff/cigarette limit, smokers' brand preference, and the act of smoking. Smokers of light or ultra-light cigarette brands (> or = 10 cigarettes/day, 16 men and 16 women) participated in this within-subjects protocol. Prior to each of the four, Latin-square ordered, approximately 2.5-h sessions, subjects abstained from smoking for at least 8 h. In each session, subjects smoked eight puffs, at 30-min intervals, from either their own brand of cigarettes, a marketed brand that was not their own, de-nicotinized tobacco cigarettes, or the novel smoking system. Subjective and physiological effects were assessed regularly. Results confirmed previous observations that the withdrawal suppression, CO intake, and tachycardia produced by the novel system are all less than that produced by normally marketed cigarette brands, even controlling for the system's eight-puff limitation and for brand preference. Incomplete withdrawal suppression may increase smoking frequency, thus potentially offsetting any decreased risks associated with Accord use. Laboratory studies of the acute effects of novel smoking systems are an important part of a comprehensive evaluation program.

Preliminary evaluation of a novel smoking system: effects on subjective and physiological measures and on smoking behavior.

Tobacco companies are responding to public pressure to market less dangerous and aversive products by developing novel smoking systems. The short- and long-term effects of these systems must be evaluated to determine the risks inherent in their use. One such system, the Accord, uses a hand-held device to heat tobacco electronically and is marketed as a means to reduce second-hand smoke. In this study 10 cigarette smokers (> or = 10 cigarettes per day) were recruited to evaluate the short-term effects produced when using this system. Subjects abstained from smoking for at least 8 h before participating in two experimental sessions where they smoked either their usual brand or used the Accord at 30-min intervals for 2 hours. Subject-rated measures of tobacco withdrawal and craving, physiological measures, and smoking behavior were assessed within each session. Results show that, when using the Accord, the magnitude of smoking-induced craving reductions and the physiological effects of smoking were less, and puff volume and frequency were greater than when subjects smoked their own brand of cigarettes. The expired air carbon monoxide increases observed after smoking own brand cigarettes did not occur after using the Accord. The novel system does not provide maximal withdrawal suppression and produces little increase in expired air carbon monoxide; physiological data suggest that the novel system may deliver nicotine less efficiently than normally marketed cigarettes. Smokers using the Accord system may smoke more often or more intensely to compensate for decreased withdrawal suppression and/or nicotine delivery.

Relative potency of levo-alpha-acetylmethadol and methadone in humans under acute dosing conditions.

levo-alpha-Acetylmethadol (LAAM) and methadone are full mu-opioid agonists used to treat opioid dependence. Current labeling indicates that LAAM is less potent than methadone. Clinical studies have not determined the relative potency of these drugs. This study compared the effects of acute doses of LAAM and methadone and also examined the ability of naloxone to reverse their effects. Five occasional opioid users received once weekly doses of either placebo, LAAM, or methadone (15, 30, or 60 mg/70 kg p.o.) in agonist exposure sessions and then received naloxone (1.0 mg/70 kg i.m.) 24, 72, and 144 h after agonist exposure. Subject-rated, observer-rated, and physiological measures were assessed regularly. Comparisons of physiological and subjective measures collected in agonist exposure sessions indicate that LAAM is not less potent than methadone under acute dosing conditions. For some measures, LAAM was significantly more potent. Three subjects who entered the study were withdrawn for safety reasons due to greater than anticipated and clinically relevant respiratory depression after receiving 60 mg of LAAM. Naloxone did not fully reverse the pupil constriction produced by 60 mg of LAAM. Acute agonist effects suggest that LAAM may be more potent than methadone and more potent than current labeling indicates. An accurate LAAM:methadone relative potency estimate will aid determination of adequate doses for opioid-dependent patients inducted onto LAAM and for methadone maintenance patients who choose to switch to more convenient thrice-weekly LAAM.