View Clinical Trial (Medical Research Study)
Smoking Cessation Intervention for Diabetic Patients
| City: |
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Providence |
| State: |
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Rhode Island |
| Zip Code: |
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02903 |
| Conditions: |
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Smoking - Type 2 Diabetes |
| Purpose: |
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This study is designed to develop and test a smoking cessation intervention for smokers with
Type 2 diabetes.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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| NCT ID: |
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NCT01501877 |
| Primary Contact: |
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Principal Investigator
Susan E. Ramsey, Ph.D.
Rhode Island Hospital
Susan E Ramsey, Ph.D.
Phone: 4014447831
Email: sramsey@lifespan.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Providence, Rhode Island 02903
United States
Susan E. Ramsey, Ph.D.
Phone: 401-444-7831
Email: sramsey@lifespan.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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