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Behavioural Intervention

CIS/No loz/no email/lite website/full booklet for Smoking Cessation (NCI Trial)

Phase 4
Waitlist Available
Led By Timothy B Baker, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(1). Interest in quitting smoking within the next 30 days, but not already actively engaged in quitting (e.g., subject should not be currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). The person has a phone and has home internet access; (3). The person has an email address that can be used to send assessments, and deliver email prompts; (4). The person expresses willingness to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes ≥ 5 cpd; (7). The person is ≥ 18 years;(8). The person accesses the internet with no more than 3 computers/devices (including devices such as iPads and smartphones); and (9). No other members of the person's household are participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) Subjects will not have to express an interest in using NRT. They may be sent NRT depending upon experimental assignment, but a commitment to use medication is not a requirement of participation. Also, pregnant smokers, or those who believe they may become pregnant, can participate, but they will be randomly assigned to only the non-medication treatments and participate only in the substudy. \[They will not be included in the regular data analyses, and power will be too small to permit meaningful inferential tests. However, effect sizes in this small group of smokers will be determined for comparison with the effect sizes obtained in the main study.\] Due to limitations in the volume of new calls that can be handled in the phone counseling component, recruitment will not exceed 300 per month. When monthly recruitment goal has been met, the recruitment invitation will be turned off until the following month. At the point where it is necessary to achieve the desired (50/50) gender balance, the invitation to participate in the study will be restricted by sex until full enrollment is achieved.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collected at all assessments (measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). analyzed after the study.
Awards & highlights

Summary

This is an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites \[smokefree.gov \& women smokefree.gov\], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones.

Eligible Conditions
  • Smoking Cessation
  • Smoking
  • Nicotine Addiction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected at all assessments (measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). analyzed after the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and data collected at all assessments (measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). analyzed after the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
7-Day Point-Prevalence Abstinence From Smoking
Secondary study objectives
Effectiveness of the Experimental Resources.
Increased Quit Attempts
Perceived Support
+4 more

Trial Design

32Treatment groups
Experimental Treatment
Group I: no CIS/no loz/no email/full website/full bookletExperimental Treatment2 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
Group II: no CIS/no loz/emails/lite web/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
Group III: no CIS/no loz/emails/full website/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
Group IV: no CIS/no loz/emails/full website/brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
Group V: no CIS/Loz/No email/lite website/brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: Does this combination of services achieve effectiveness compared to others: No CIS phone counseling, NRT lozenge, no motivational email, lite website, brief mailed booklet
Group VI: No CIS/no loz/email/lite website/brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: Does this combination of services lead to greater abstinence: No CIS counseling calls, no NRT lozenge, motivational emails, lite website, brief mailed booklet.
Group VII: No CIS/loz/no emails/full website/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
Group VIII: No CIS/loz/emails/lite website/full bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
Group IX: No CIS/loz/emails/full website/full bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet
Group X: No CIS/loz/emails/full website/brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
Group XI: No CIS/No loz/No email/lite website/full bookletExperimental Treatment2 Interventions
This arm seeks to answer the question: Does this combination of services achieve efficacy compared to others: No CIS counseling, no NRT lozenge, no motivational email, lite website, full mailed booklet
Group XII: No CIS/No loz/No email/Full website/Brief bookletExperimental Treatment2 Interventions
This arm of the project will address the following question: Does this combination of services lead to greater abstinence? No CIS counseling, no NRT lozenge, no motivational email, full website, brief mailed booklet
Group XIII: No CIS/No loz/No Email/Lite Website/Brief BookletExperimental Treatment2 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, No nicotine lozenge, No motivational emails, lite website, brief mailed booklet
Group XIV: No CIS/Loz/emails/Lite Website/brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
Group XV: No CIS/Loz/No emails/lite website/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
Group XVI: No CIS/Loz/No emails/full website/brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? No CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
Group XVII: CIS/no loz/no email/full website/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
Group XVIII: CIS/no loz/emails/lite website/full bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
Group XIX: CIS/no loz/emails/full website/full bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
Group XX: CIS/no loz/emails/full website/brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
Group XXI: CIS/loz/no email/lite website/full bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
Group XXII: CIS/loz/no email/full website/brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
Group XXIII: CIS/loz/emails/lite website/full bookletExperimental Treatment5 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
Group XXIV: CIS/loz/emails/lite website/brief bookletExperimental Treatment5 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
Group XXV: CIS/loz/emails/full website/brief bookletExperimental Treatment5 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
Group XXVI: CIS/No loz/no email/lite website/full bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, lite website, full mailed booklet
Group XXVII: CIS/No loz/no email/full website/brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, No motivational emails, full website, brief mailed booklet
Group XXVIII: CIS/No loz/No email/Lite Website/Brief bookletExperimental Treatment3 Interventions
This arm of the project will address the following question: Does the following treatment provide efficacy relative to others: CIS calls, no NRT lozenge, no motivational email, Lite website, Brief mailed booklet
Group XXIX: CIS/No loz/Emails/Lite Website/Brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, No nicotine lozenge, motivational emails, lite website, brief mailed booklet
Group XXX: CIS/Loz/no Emails/Full Website/Full BookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
Group XXXI: CIS/Loz/No email/Lite website/Brief bookletExperimental Treatment4 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, No motivational emails, lite website, brief mailed booklet
Group XXXII: CIS/Loz/Emails/Full Website/Full BookletExperimental Treatment5 Interventions
This arm of the project will address the following question: How effective is the following intervention? CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,214 Previous Clinical Trials
3,162,059 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,857 Previous Clinical Trials
41,005,670 Total Patients Enrolled
Fred Hutchinson Cancer CenterOTHER
563 Previous Clinical Trials
1,341,404 Total Patients Enrolled
~74 spots leftby Sep 2025