Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT01120704
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.
Study:
NCT01120704
Study Brief:
Protocol Section:
NCT01120704