Protocol - Cessation Milestones - Abstinence from Cigarettes

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This protocol is based on analysis of participant data of daily smoking collected during a smoking cessation trial. Three outcomes are analyzed: initial abstinence, initial lapse, and relapse. Initial lapse is of interest because it is predictive of subsequent relapse.

Specific Instructions

Cessation milestones are derived from the Amount, Type, and Frequency of Recent Cigarette Use protocol from the Tobacco Regulatory Research Collections. This protocol assumes that information on a participant’s product use (see PhenX Tobacco Regulatory Research Collection, “Amount, Type, and Frequency of Recent Cigarette Use” measure) has been collected for a study participant beginning on the target quit date.

Although this analysis refers to the use of cigarettes only, the Smoking Cessation, Harm Reduction, and Biomarkers Working Group feels that these milestone definitions can be applied to 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)

Although only the initial lapse is derived in this protocol, the Smoking Cessation, Harm Reduction, and Biomarkers Working Group feels that it could also be used to examine the occurrence of other lapses. These subsequent lapses can be defined as an episode of smoking after establishing another 24 hours of abstinence. Smoking status (current or former smoker) at study conclusion can also be determined from this protocol.

Although the participants of the study were adults aged 21-65, the Smoking Cessation, Harm Reduction, and Biomarkers Working Group suggests that the protocol could also be used for adolescents, as well as adults of any age, who are current tobacco users.


The three milestone variables were computed using smoking calendar data.

Derivation of Cessation Milestones

Three outcome milestones were recorded as defined:

Initial abstinence - Defined as 24 hrs. without smoking. Determined achievement of 24 hrs. of abstinence on the basis of a 24-hr period without any cigarette entries.

Initial lapse - The first episode of any smoking after initial cessation, whether a single puff or multiple cigarettes, recorded by participants.

Relapse - Resumption of regular smoking. Either smoking for 7 consecutive days (7-day relapse) or 5 cigarettes/day for 3 consecutive days (5-3 relapse), computed from entries of smoking episodes.



Personnel and Training Required


Equipment Needs


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

Secondary Data Analysis

Life Stage



Adult (aged 21-65) current cigarette smokers 

Selection Rationale

Identification of Cessation Milestones was selected because it is a validated and commonly reported outcome measure in cessation studies. Analyzing outcome data by the milestones of initial abstinence, lapse, and relapse may enhance understanding of cessation treatments and their mechanisms.



caDSR Common Data Elements (CDE) Smoking Abstinence from Cigarettes Milestone Category   7580703 CDE Browser
Derived Variables


Process and Review

Not Applicable

Protocol Name from Source

Shiffman, S., et al. Analyzing milestones in smoking cessation: illustration in a nicotine patch trial in adult smokers. J Consult Clin Psych, 2006.


Japuntich, S. J., Leventhal, A. M., Piper, M. E., Bolt, D. M., Roberts, L. J., Fiore, M. C., & Baker, T. B. (2011). Smoker characteristics and smoking-cessation milestones. American Journal of Preventive Medicine, 40(3), 286-294.

Shiffman, S., Scharf, D. M., Shadel, W. G., Gwaltney, C. J., Dang, Q., Paton, S. M., & Clark, D. B. (2006). Analyzing milestones in smoking cessation: Illustration in a nicotine patch trial in adult smokers. Journal of Consulting and Clinical Psychology, 74(2), 276-285.

General References

Japuntich, S. J., Piper, M. E., Leventhal, A. M., Bolt, D. M., & Baker, T. B. (2011). The effect of five smoking cessation pharmacotherapies on smoking cessation milestones. Journal of Consulting and Clinical Psychology, 79(1), 34-42.

Sobell, L. C., Sobell, M. B., Buchan, G., Cleland, P. A., Fedoroff, I., & Leo, G. I. (1996, November). The reliability of the Timeline Followback method applied to drug, cigarette, and cannabis use. Presented at the 30th annual meeting of the Association for Advancement of Behavior Therapy, New York, NY.

Protocol ID


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

Cessation Milestones - Abstinence from Cigarettes

Release Date

February 23, 2021


Milestones of abstinence involve use of daily diaries to record product use for each day. This information can then be used to analyze three different outcome milestones: initial abstinence (first 24 hours with no use), lapse date (first day of smoking since initial abstinence), and relapse date (first day of 7 consecutive days of smoking or 5 cigarettes/day for 3 consecutive days since initial abstinence).


Abstinence is defined as not using specified tobacco products over a specified time period. This is an assessment to identify participants who have been successful in cessation trials, as well as associations with dependence and related genotypes; it is the primary outcome in many cessation studies. Analyzing milestones allows researchers to distinguish the effects of treatment on intermediate outcomes before continuous long-term abstinence. Through milestones, it is possible to examine the cessation process and identify the ability to establish initial abstinence and determine the effectiveness of treatment in delaying initial lapse or preventing or delaying subsequent relapse.


Smoking Cessation, Harm Reduction, and Biomarkers, smoking, quitting smoking, quit, abstinence, milestones, initial abstinence, lapse, relapse, timeline follow-back, TLFB