Preferences for Reduced Nicotine Cigarettes in Smokers

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: Test products, dosages and route of administration Very low nicotine cigarette MAGIC 0, crafted with carbon filter (Federal Trade Commission [FTC] nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc). This brand of VLNC (called MAGIC 0), manufactured by 22nd Century Group, Inc, has recently became available on the Europe market (although they are not available in New Zealand). Similar to the previously developed MAGIC, MAGIC 0 cigarettes yield only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands. It has been claimed that the proprietary tobacco used in MAGIC 0 cigarettes has the taste of a conventional cigarette, but with lower‐addictive levels of nicotine. According to the company, the addition of a carbon filter reduces toxic compounds in the smoke, and provides a full air flow smoking experience, making it different from previous products (e.g., MAGIC). Each participant will be allocated to smoke one MAGIC 0 and one MAGIC cigarette at the study site. Participant will smoke each cigarette as closely as possible to their normal smoking pattern. After smoking each cigarette participants will be given a 45 minute washout period in order to complete the evaluation questionnaire and to allow most of the inhaled nicotine to be metabolised (nicotine has a half‐life in plasma of nine minutes). Reference therapy Very low nicotine cigarette MAGIC (FTC nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc). CONDITION: Smoking behaviour PRIMARY OUTCOME: Acceptability as measured using the satisfaction domain of the modified Cigarette Evaluation Questionnaire (mCEQ). This domain includes the three questions: ; ; 1) Was smoking satisfying? ; 2) Did the cigarettes taste good? ; 3) Did you enjoy smoking? ; ; These questions will be self‐rated by participants on a seven‐point likert scale (1‐not at all, 2 very little, 3‐a little, 4‐moderately, 5‐a lot, 6‐quite a lot, 7‐extremely). An average of the three questions will be obtained to achieve a single overall measure of smoking satisfaction. ; SECONDARY OUTCOME: Characteristics of the cigarette smoke ; ; 1) How strong did you find the cigarette smoke? ; 2) How hot did you find the cigarette smoke? ; 3) How hard was it to draw smoke from the cigarette? ; 4) How harsh did you find the cigarette smoke? ; 5) How intense did you find the flavour of the cigarette smoke? ; 6) How thick did you find the cigarette smoke? ; 7) How fresh did you find the cigarette smoke? ; 8) How heavy did you find the cigarette smoke? ; 9) How similar in taste did you find the cigarette compared to your usual brand? ; ; All items will be self‐rated by the participant on a seven‐point scale from one (“not at all”) to seven (“extremely”). Craving reduction measured by the mCEQ ; ; 1) Did smoking immediately relieve your craving for a cigarette? ; ; These questions will be self‐rated by participants on a seven‐point Likert scale (1‐not at all, 2 very little, 3‐a little, 4‐moderately, 5‐a lot, 6‐quite a lot, 7‐extremely). Negative effects measured by the mCEQ ; ; 1) Did smoking make you dizzy? ; 2) Did smoking make you nauseous? ; ; ; 1) Did smoking calm you down? ; 2) Did smoking make you feel more awake? ; 3) Did smoking make you feel less irritable? ; 4) Did smoking help you concentrate? ; 5) Did smoking reduce your hunger for food? Respiratory tract sensations from the mCEQ: ; ; 1) Did you enjoy the sensations in your throat and chest? ; ; These questions will be self‐rated by participants on a seven‐point Likert scale (1‐not at all, 2 very little, 3‐a little, 4‐moderately, 5‐a lot, 6‐quite a lot, 7‐extremely). ; These questions will be self‐rated by participants on a seven‐point Likert scale (1‐not at all, 2 very little, 3‐a little, 4‐moderately, 5‐a lot, 6‐quite a lot, 7‐extremely). Psychological Reward: measured by the mCEQ INCLUSION CRITERIA: Participants will be eligible for inclusion in the study if they: are daily smokers of non‐menthol tobacco cigarettes are willing and able to attend the study site for the entire duration of the study; are at least 18 years of age; have their first cigarette within 30 minutes of waking; self‐report being in good health; are able to give written consent; are able to read and write English.
Epistemonikos ID: 28ce0b8d87037cc86f0ebe2850cf82c8c660e119
First added on: Aug 25, 2024