Protocol - Cessation Milestones - Abstinence from Cigarettes
- Expired Carbon Monoxide
- Nicotine Metabolite Ratio - Serum and Saliva
- Prolonged Abstinence from Tobacco Products
- Smoking Quit Attempts
Description
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:
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)
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.
Availability
This protocol is freely available; permission not required for use.
Protocol
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
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
Secondary Data Analysis
Lifestage
Adult
Participants
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.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| caDSR Form | PX330101 Phenx Cessation Milestone | 14350122 | caDSR Form |
Derived Variables
None
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.
Source
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
330101
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX330101_Cessation_Milestones_Cigarettes_Abstinence_First_Lapse | ||||
| PX330101020000 | When was the participant's first lapse? The more | N/A | ||
| PX330101_Cessation_Milestones_Cigarettes_Abstinence_Initial | ||||
| PX330101010000 | When was the participant first abstinent? more | N/A | ||
| PX330101_Cessation_Milestones_Cigarettes_Abstinence_Relapse | ||||
| PX330101030000 | When did the participant relapse? Resumption more | N/A | ||