Protocol - Point-Prevalence Abstinence from Tobacco Products
Two questions asking current smokers about their use of defined tobacco products in the past 7 days or 30 days.
Although this question asks about the use of cigarettes only, the Smoking Cessation, Harm Reduction, and Biomarkers Working Group feels that this question can be asked about other tobacco products. When asking about multiple products, this protocol can define the types of tobacco products from which the participants are required to abstain. Specify each product you are asking about, for example:
Other combustible tobacco products (e.g., cigars or cigarillos)
Smokeless tobacco products (e.g., snus, chew)
Alternative tobacco products (e.g., electronic cigarette, vape, heat-not-burn products)
The Smoking Cessation, Harm Reduction, and Biomarkers Working Group recommends that the protocol can be used for adolescent or adult current smokers via either an interviewer- or self-administered questionnaire.
Please note that the wording for these questions has recently been updated by a Society for Research on Nicotine and Tobacco (SRNT) Working Group and is available in Piper et al (2020).
1. Have you smoked a cigarette, even a puff, in the past 30 days?
[ ] 1 Yes
[ ] 2 No
[ ] 3 Don’t know
[ ] 4 Refused
If Question 1 is “Yes,” then respondent is asked:
2. Have you smoked a cigarette, even a puff, in the past 7 days?
[ ] 1 Yes
[ ] 2 No
[ ] 3 Don’t know
[ ] 4 Refused
Personnel and Training Required
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Adult (aged 55–79) current smokers
This protocol was chosen for being broadly applicable and generally accepted, being low burden to participants and investigators and for being the standard published by the Society for Research on Nicotine and Tobacco.
|caDSR Common Data Elements (CDE)||Smoking Point-prevalence Abstinence Yes No Unknown Refused Indicator||7582575||CDE Browser|
Process and Review
Protocol Name from Source
Program for Lung Cancer Screening and Tobacco Cessation (PLUTO), 2015-2020
Fu, S. S., Rothman, A. J., Vock, D. M., Lindgren, B., Almirall, D., Begnaud, A., Melzer, A., Schertz, K., Glaeser, S., Hammett, P., & Joseph, A. M. (2017). Program for lung cancer screening and tobacco cessation: Study protocol of a sequential, multiple assignment, randomized trial. Contemporary Clinical Trials, 60, 86–95.
Benowitz, N. L., Bernert, J. T., Foulds, J., Hecht, S., Jacob, P., Jarvis, M. J., Joseph, A., Oncken, C., & Piper, M. E. (2020). Biochemical verification of tobacco use and abstinence: 2019 update. Nicotine & Tobacco Research, 22(7), 1086–1097.
Hughes, J. R., Keely, J. P., Niaura, R. S., Ossip-Klein, D. J., Richmond, R. L., & Swan, G. E. (2003). Measures of abstinence in clinical trials: Issues and recommendations. Nicotine & tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco, 5(1), 13–25.
Muramoto, M. L., Leischow, S. J., Sherrill, D., Matthews, E., & Strayer, L. J. (2007). Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation. Archives of Pediatrics & Adolescent Medicine, 161(11), 1068–1074.
Piper, M. E., Bullen, C., Krishnan-Sarin, S., Rigotti, N. A., Steinberg, M. L., Streck, J. M., & Joseph, A. M. (2020). Defining and measuring abstinence in clinical trials of smoking cessation interventions: An updated review. Nicotine & Tobacco Research, 22(7), 1098–1106.
Tonstad, S., Tønnesen, P., Hajek, P., Williams, K. E., Billing, C. B., Reeves, K. R. (2006) Effect of maintenance therapy with varenicline on smoking cessation: A randomized controlled trial. JAMA, 296(1), 64–71.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
Point-Prevalence Abstinence from Tobacco Products
February 14, 2022
Question to assess abstaining from defined tobacco products during a specific prior interval immediately preceding follow-up.
Abstinence is defined as not using specified tobacco products over a specified time period. This assessment identifies participants who have achieved abstinence following treatment in cessation clinical trials, as well as associations with dependence and related phenotypes and genotypes; it is the primary outcome in many cessation studies. Point-prevalence abstinence is a snapshot describing complete abstinence during a designated time period (e.g., 7 days or 30 days) prior to assessment.
Point-prevalence abstinence has several advantages as an outcome measure. First, it relies on more proximal behavior than other abstinence measures. Second, it allows for biochemical verification that is more likely to be valid than for prolonged or continuous abstinence due to half-lives of various biomarkers.
Smoking cessation, harm reduction, and biomarkers; smoking; quitting smoking; quit; abstinence; point-prevalence; point prevalence; Program for Lung Cancer Screening and Tobacco Cessation; PLUTO
|Protocol ID||Protocol Name|
|330601||Point-Prevalence Abstinence from Tobacco Products|
There are no publications listed for this protocol.