Nicotine Threshold: Establishing a Pilot Protocol

Principal Investigator: Cliff Watson / Sarah Evans

Funding Mechanism: Interagency Agreement

ID number: 224-11-9002

Award Date: 3/21/2011

Institution: Centers for Disease Control and Prevention

Reducing the nicotine content in cigarettes may facilitate cessation and discourage initiation. However, in order to maintain a desired nicotine dose, smokers might change their smoking behaviors (i.e., increase “compensatory smoking”) to maximize nicotine uptake, thus increasing their exposure to smoke constituents. The goal of this un-blinded clinical study was to study the effects of low-nicotine cigarettes on smoking behavior by using solanesol as a marker for exposure to smoke constituents. Investigators analyzed solanesol levels in approximately 2,500 cigarette butts collected by 72 participants smoking 39 different cigarette brands over four weeks. Participants smoked their own brand of cigarette (approximately 12 mg nicotine/cigarette) during the first week; Quest 1 (6 mg nicotine/cigarette) during the second week; Quest 2 (3 mg nicotine/cigarette) during the third week; and Quest 3 (0.05 mg nicotine/cigarette) during the fourth week. Study findings indicate that participants demonstrated moderate compensation when smoking cigarettes with minor nicotine reduction, did not compensate by smoking more cigarettes per day, and demonstrated minimal compensation when smoking cigarettes with major nicotine reduction. These data may be used to inform FDA’s regulatory activities.