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Protocol - Prolonged Abstinence from Tobacco Products

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Description

Two questions asking current tobacco users about their use of specific tobacco products since the end of an initial grace period. The grace period is a length of time (typically lasting 1–2 weeks after the target quit date [TQD]) during which smoking is permitted by the investigator. This grace period enables abstinence to be established.

Specific Instructions

The recommended timing of the assessment should be based on the research question and should be assessed at the end of treatment, 3 months after the end of treatment, and 6 months post–target quit date, or other previously defined outcome intervals.

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)

Some definitions of prolonged abstinence may tolerate lapses or “slips” (but not relapse) after the grace period, thus better reflecting the realities of quitting smoking. If lapses are permitted, the abstinence definition should specify, a priori, the number and timing of lapses allowed.

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. Since [the end of the grace period] have you ever smoked at least a part of a cigarette on each of 7 consecutive days?

[ ] 1 Yes

[ ] 2 No

[ ] 3 Don’t know

[ ] 4 Refused

If Question 1 is “No,” then respondent is asked:

2. After [the end of the grace period] have you smoked any in each of 2 consecutive weeks?

[ ] 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

Self-administered questionnaire

Lifestage

Adult, Senior

Participants

Adult (aged 18 or older) current smokers

Selection Rationale

This protocol was chosen for being broadly applicable and generally accepted, being low burden to participants and investigators, and being the standard published by the Society for Research on Nicotine and Tobacco.

Language

English

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Smoking Prolonged Abstinence Yes No Unknown Refused Indicator 7582621 CDE Browser
Derived Variables

None

Process and Review

Not applicable

Protocol Name from Source

Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care, 2016-2019.

Source

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.

U.S. Department of Veterans Affairs, Office of Research and Development (2016, May–2019, April) Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care. Identification No. NCT02500589. https://clinicaltrials.gov/ct2/show/NCT02500589

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.

Ferguson, J., Bauld, L., Chesterman, J., & Judge, K. (2005). The English smoking treatment services: One-year outcomes. Addiction (Abingdon, England), 100(Suppl. 2), 59–69.

Gierisch, J. M., Bastian, L. A., Calhoun, P. S., McDuffie, J. R., & Williams, J. W., Jr. (2012). Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. Journal of General Internal Medicine, 27(3), 351–360.

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.

Protocol ID

330701

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
Smoking Cessation, Harm Reduction and Biomarkers
Measure Name

Prolonged Abstinence from Tobacco Products

Release Date

January 1, 1970

Definition

Question to assess complete abstinence from defined tobacco products after an initial grace period or during a period of sustained abstinence between two assessment dates.

Purpose

Abstinence is defined as not using specified tobacco products over a certain time period. This is an assessment to identify people who have achieved abstinence as a result of participation in a smoking cessation clinical trial, as well as associations between abstinence and dependence and related phenotypes and genotypes; it is the primary outcome in many smoking cessation studies. Prolonged (or sustained) abstinence describes continuous abstinence following an initial grace period. The grace period is a time frame after the target quit date (TQD), during which smoking is permitted by the investigator to allow for abstinence to be achieved if a person is unable to quit on his or her TQD (e.g., 1-2 weeks).

Keywords

Smoking cessation, harm reduction, and biomarkers; smoking; quitting smoking; quit; abstinence; prolonged abstinence; sustained abstinence; target quit date; TQD

Measure Protocols
Protocol ID Protocol Name
330701 Prolonged Abstinence from Tobacco Products
Publications

There are no publications listed for this protocol.