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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to develop and test a smoking cessation intervention for smokers with Type 2 diabetes.

Condition or disease Intervention/treatment
Smoking Type 2 Diabetes Behavioral: Acceptance and Commitment Therapy Behavioral: Standard smoking cessation intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smoking Cessation Intervention for Diabetic Patients
Study Start Date : December 2011
Primary Completion Date : April 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Susan E. Ramsey, Ph.D. Rhode Island Hospital
More Information

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01501877     History of Changes
Other Study ID Numbers: DA030532
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Rhode Island Hospital:
Smoking
Type 2 Diabetes
Smoking cessation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases