Clinical Trials

Prolonged Smoking Cessation Using Prescription Step Care

Location:

Trial status:

Inactive

Why is this study being done?

A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. Despite a high degree of interest in applying the step care model to smoking cessation (Abrams et al., 1996; Hughes, 1994), little empirical work has been conducted utilizing this treatment approach. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

Who is eligible to participate?

Cigarette smokers who are 18 years of age or older, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. Potential participants must agree to commit to the study for at least 24 months, be screened and agree to potentially participate in more intensive interventions to help them stop smoking, and agree to not seek other treatment for smoking cessation during the treatment phase of the study.

What is involved?

You are being asked to take part in this research study because you intend to stop smoking tobacco cigarettes. You will be put in one of two groups by chance (as in the flip of a coin). The two treatment groups are:

• Smoking cessation interventions consisting of a brief physician visit, one session of counseling, and 6 weeks of using the nicotine patch. This intervention will be repeated as needed (in the event you have not quit smoking or have relapsed) at the six and twelve month visits, with final follow-up visits at 18 and 24 months.


• Smoking cessation intervention plus Step Care - The initial visit will be the same as described above. Then, if needed at 6 months because you have not stopped smoking or have relapsed, the medication Zyban® will be prescribed along with 4 sessions of counseling. At one year, if needed, monitored use of the nicotine patch and nicotine gum will be provided along with 6 additional sessions of counseling. Final follow-up visits will be conducted at 18 and 24 months.

All of the treatment sessions will be audio taped, and a portion of these will be selected for review by the investigators. The purpose of this is for therapist training and monitoring. All information contained in the treatment sessions will be kept strictly confidential by Mayo.

It is very important that you tell your study doctor or nurse about all medical problems you have now or have had in the past, medications you have been taking, or allergic reactions you have had to medications, foods, etc.

How long is the study?

Participants will be enrolled in this research study for up to two years.

Last updated: 06/29/2011

NCT ID: NCT00170079

IRB Number:1730-04