Clinical trial NCT01120704
Conditions: Smoking Smoking Cessation Adherence Nicotine Dependence Motivation
Keywords: Smoking Smoking Cessation Adherence Nicotine Motivation
Sponsor: University of Wisconsin, Madison
Start date: 2010-06-01; Completion date: 2014-05-01
Enrollment: 544 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

Detailed description:
Nonadherent use of smoking cessation medications is very common and highly associated with cessation failure. However, little is presently known about how to improve adherence and whether improved adherence will actually boost cessation success (i.e., its causal role is unknown). This research represents groundbreaking integration of 1) basic theory and data on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art Intervention Optimization Cycle methodology. This methodology uses factorial designs to efficiently engineer and evaluate intervention components, and to develop an optimal comprehensive treatment package. Participants in Project 3 will be smokers (N = 544) visiting primary care clinics for a regular outpatient visit who, when asked, express an interest in quitting and agree to participate in a smoking cessation research study. The experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a 50% chance of being assigned one of the levels of each factor. The five factors include one medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone; and 3) automated adherence prompting phone calls vs. no prompting.

Arms: arm 1: This 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 arm 2: This 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 arm 3: This 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 arm 4: This 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 arm 5: This 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 arm 6: This 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 arm 7: This 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 arm 8: This 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 arm 9: This 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 arm 10: This 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 arm 11: This 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 arm 12: This 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 arm 13: This 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 arm 14: This 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 arm 15: This 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 arm 16: This 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 arm 17: This 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 arm 18: This 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 arm 19: This 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 arm 20: This 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 arm 21: This 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 arm 22: This 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 arm 23: This 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 arm 24: This 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 arm 25: This 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 arm 26: This 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 arm 27: This 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 arm 28: This 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 arm 29: This 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 arm 30: This 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 arm 31: This 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 arm 32: This 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: intervention 1: Short Term Combination Nicotine Replacement Therapy (patch + gum) intervention 2: Long Term Combination Nicotine Replacement Therapy (patch + gum) intervention 3: Intensive Maintenance Counseling intervention 4: Cognitive Medication Adherence Counseling (CAM) intervention 5: Electronic Medication Monitoring Device (the Helping Hand) + Feedback intervention 6: Automated Adherence Prompting Phone Calls
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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). intervention 6: 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.

Protocol documents: