At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
In Brief
A Phase 3 clinical trial evaluating Telephone Counseling and Nicotine Patches for Smoking Cessation. Completed, enrolled 243 participants across 1 site.
Detailed Summary
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to: 1. See if subjects will use pre-cessation nicotine patches. 2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches. 3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day. 4. See if sending 2-weeks' worth of patches is helpful to the quitting process.
Study Details
Timeline
Interventions
Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels). For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.