跳至主要内容
临床试验/NCT01501877
NCT01501877已完成不适用

Smoking Cessation Intervention for Diabetic Patients

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Point prevalence abstinence from smoking

研究概览

简要总结

This study is designed to develop and test a smoking cessation intervention for smokers with Type 2 diabetes.

详细描述

Individuals with Type 2 diabetes smoke at rates similar to those found in the general population, and the health consequences of smoking are particularly severe among smokers with diabetes. In fact, there appears to be a synergistic effect between smoking and diabetes on mortality. However, despite reports that highlight the importance of this work, a paucity of studies have been conducted to develop and test smoking cessation interventions tailored to meet the needs of individuals with diabetes. The small number of extant studies have yielded mixed results. Distress tolerance (DT) focused, acceptance-based interventions have demonstrated efficacy for smoking cessation, and there is increasing support for the conceptual model underlying these interventions among individuals with diabetes. The long-term objective of this research program is to improve smoking cessation treatment for individuals with Type 2 diabetes by developing and establishing the efficacy of a DT smoking cessation intervention tailored to this population. Furthermore, we seek to advance knowledge of the relationships among nicotine withdrawal, negative affect, distress tolerance, and smoking cessation outcomes among individuals with diabetes.

In the present study, we will develop a DT intervention tailored to meet the needs of smokers with Type 2 diabetes. In the first phase of this project, we will develop and pilot the intervention with 18 patients. In the second phase of the project, we will conduct a preliminary, randomized trial with 54 patients to examine the efficacy of the DT intervention relative to a standard smoking cessation treatment (ST) that equates for therapist contact time. Patients in both conditions will receive the transdermal nicotine patch.

We expect that, relative to the ST condition, patients randomized to the DT condition will have increased likelihood of smoking abstinence and increased latency to both smoking lapse and relapse. If the efficacy of this intervention can be established in this trial and in subsequent large scale randomized controlled trials, smokers with diabetes will have improved smoking cessation treatment options. The need for this work is great given the paucity of extant work in this area, the significantly heightened risk of morbidity and mortality from smoking among diabetic patients, the rapidly increasing rate of diabetes in the U.S., and an apparent stabilization of the smoking rate in recent years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21 years of age or older
  • Type 2 diabetes
  • regular smoker for at least 3 years
  • smoke an average of more than 10 cigarettes per day
  • report motivation to quit smoking of at least 5 out of 10
  • speak English

排除标准

  • current alcohol abuse or dependence
  • current substance abuse or dependence (excluding nicotine)
  • psychotic
  • form of diabetes other than Type 2
  • medical condition that is a contraindication for the transdermal nicotine patch
  • using pharmacotherapy for smoking cessation
  • using other tobacco products
  • unable to provide names and contact information for locators
  • no access to a telephone

结局指标

主要结局

Point prevalence abstinence from smoking

时间窗: 26 weeks from smoking quit date

We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Smoking Cessation Intervention for Diabetic Patients | 临床试验