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Protocol - Point-Prevalence Abstinence from Tobacco Products

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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).

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

Availability

Available

Personnel and Training Required

None

Equipment Needs

None

Requirements
Requirement CategoryRequired
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
StandardNameIDSource
caDSR Common Data Elements (CDE) Smoking Point-prevalence Abstinence Yes No Unknown Refused Indicator 7582575 CDE Browser
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 IDVariable DescriptiondbGaP Mapping
Smoking Cessation, Harm Reduction and Biomarkers
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.