Protocol - Prolonged Abstinence from Tobacco Products
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.
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:
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).
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
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 18 or older) current smokers
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.
|caDSR Common Data Elements (CDE)||Smoking Prolonged Abstinence Yes No Unknown Refused Indicator||7582621||CDE Browser|
Process and Review
Protocol Name from Source
Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care, 2016-2019.
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
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.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
Prolonged Abstinence from Tobacco Products
January 1, 1970
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.
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).
Smoking cessation, harm reduction, and biomarkers; smoking; quitting smoking; quit; abstinence; prolonged abstinence; sustained abstinence; target quit date; TQD
|Protocol ID||Protocol Name|
|330701||Prolonged Abstinence from Tobacco Products|
There are no publications listed for this protocol.