Protocol - Point-Prevalence Abstinence from Tobacco Products
- Expired Carbon Monoxide
- Motivation to Quit - Multiple Item
- Motivation to Quit - Single Item
- Smoking Quit Attempts
Description
Two questions asking current smokers about their use of defined tobacco products in the past 7 days or 30 days.
Specific Instructions
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:
Cigarettes
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).
Availability
Protocol
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
None
Equipment Needs
None
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Interviewer-administered questionnaire
Lifestage
Adult, Senior
Participants
Adult (aged 55–79) current smokers
Selection Rationale
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.
Language
English
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
Not applicable
Protocol Name from Source
Program for Lung Cancer Screening and Tobacco Cessation (PLUTO), 2015-2020
Source
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.
General References
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.
Protocol ID
330601
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping |
|---|
Measure Name
Point-Prevalence Abstinence from Tobacco Products
Release Date
February 14, 2022
Definition
Question to assess abstaining from defined tobacco products during a specific prior interval immediately preceding follow-up.
Purpose
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.
Keywords
Smoking Cessation, Harm Reduction, and biomarkers; smoking; quitting smoking; quit; abstinence; point-prevalence; point prevalence; Program for Lung Cancer Screening and Tobacco Cessation; PLUTO
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 330601 | Point-Prevalence Abstinence from Tobacco Products |
Publications
There are no publications listed for this protocol.