Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Adherence
Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
2 other identifiers
interventional
544
1 country
1
Brief Summary
Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
February 16, 2015
CompletedDecember 11, 2015
November 1, 2015
3.9 years
May 3, 2010
January 29, 2015
November 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-Reported 7-Day Point-Prevalence Abstinence
Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence.
Assessed at 52 weeks after target quit day
Secondary Outcomes (1)
Latency to Relapse
Assessed during the first 12 months post-quit after target quit day
Study Arms (32)
1, 26Wks, Counseling, CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
2, 26Wks, Counseling, CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
3, 26Wks, Counseling, CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
5, 26Wks, Counseling, No CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
17, 8Wks, Counseling, CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
18, 8Wks, Counseling, CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
19, 8Wks, Counseling, CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
21, 8Wks, Counseling, No CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
25, 8Wks, No Counseling, CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback
32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback
EXPERIMENTALThis arm of the project will address the following question: How effective is the following intervention?: 8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback
Interventions
IF participant smokes \>10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment. IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
IF the participant smokes \>10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment. IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 \& 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.
Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.
If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).
Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication. Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 \& 23.
Eligibility Criteria
You may qualify if:
- years of age or older;
- Report smoking at least 5 cigarettes per day for the previous 6 months;
- Able to read and write English;
- Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
- Plans to remain in the intervention catchment area for at least 12 months;
- Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
- All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.
You may not qualify if:
- Study candidate is pregnant, trying to get pregnant, or nursing.
- A history of psychosis or bipolar disorder
- A history of skin or allergic reactions while using a nicotine patch.
- Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Dean Health Systemcollaborator
- Mercy Health Systemcollaborator
- Wake Forest University Health Sciencescollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711, United States
Related Publications (4)
McCarthy DE, Piasecki TM, Lawrence DL, Jorenby DE, Shiffman S, Baker TB. Psychological mediators of bupropion sustained-release treatment for smoking cessation. Addiction. 2008 Sep;103(9):1521-33. doi: 10.1111/j.1360-0443.2008.02275.x.
PMID: 18783504BACKGROUNDTheodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PMID: 37335995DERIVEDSchlam TR, Baker TB, Smith SS, Bolt DM, McCarthy DE, Cook JW, Hayes-Birchler T, Fiore MC, Piper ME. Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse. Nicotine Tob Res. 2020 Oct 29;22(11):2051-2058. doi: 10.1093/ntr/ntaa116.
PMID: 32598468DERIVEDSchlam TR, Cook JW, Baker TB, Hayes-Birchler T, Bolt DM, Smith SS, Fiore MC, Piper ME. Can we increase smokers' adherence to nicotine replacement therapy and does this help them quit? Psychopharmacology (Berl). 2018 Jul;235(7):2065-2075. doi: 10.1007/s00213-018-4903-y. Epub 2018 Apr 25.
PMID: 29696311DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stevens Smith
- Organization
- UWisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Michael C Fiore, MD, MPH, MBA
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
- STUDY DIRECTOR
Tanya R Schlam, PhD
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 11, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
December 11, 2015
Results First Posted
February 16, 2015
Record last verified: 2015-11