Smoking Cessation Intervention for Diabetic Patients (SSTOP)
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|ClinicalTrials.gov Identifier: NCT01501877|
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : April 12, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Smoking Type 2 Diabetes||Behavioral: Acceptance and Commitment Therapy Behavioral: Standard smoking cessation intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Smoking Cessation Intervention for Diabetic Patients|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Distress Tolerance
Acceptance and Commitment Therapy based Distress Tolerance (DT) smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
Behavioral: Acceptance and Commitment Therapy
The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
Active Comparator: Standard Smoking Cessation
Standard smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
Behavioral: Standard smoking cessation intervention
Standard smoking cessation intervention based on clinical practice guidelines.
- Point prevalence abstinence from smoking [ Time Frame: 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.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- current alcohol abuse or dependence
- current substance abuse or dependence (excluding nicotine)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501877
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Susan E. Ramsey, Ph.D.||Rhode Island Hospital|
|Responsible Party:||Rhode Island Hospital|
|Other Study ID Numbers:||
|First Posted:||December 30, 2011 Key Record Dates|
|Last Update Posted:||April 12, 2017|
|Last Verified:||April 2017|
Type 2 Diabetes
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases