Smoking Cessation Intervention for Diabetic Patients (SSTOP)
Primary Purpose
Smoking, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Standard smoking cessation intervention
Sponsored by

About this trial
This is an interventional treatment trial for Smoking focused on measuring Smoking, Type 2 Diabetes, Smoking cessation
Eligibility Criteria
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
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Distress Tolerance
Standard Smoking Cessation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Point prevalence abstinence from smoking
We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01501877
First Posted
December 21, 2011
Last Updated
April 10, 2017
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01501877
Brief Title
Smoking Cessation Intervention for Diabetic Patients
Acronym
SSTOP
Official Title
Smoking Cessation Intervention for Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to develop and test a smoking cessation intervention for smokers with Type 2 diabetes.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Type 2 Diabetes
Keywords
Smoking, Type 2 Diabetes, Smoking cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distress Tolerance
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Smoking Cessation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Standard smoking cessation intervention
Intervention Description
Standard smoking cessation intervention based on clinical practice guidelines.
Primary Outcome Measure Information:
Title
Point prevalence abstinence from smoking
Description
We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.
Time Frame
26 weeks from smoking quit date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E. Ramsey, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Cessation Intervention for Diabetic Patients
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