Smoking Cessation Intervention for Diabetic Patients (SSTOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Rhode Island Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01501877
First received: December 21, 2011
Last updated: December 27, 2011
Last verified: December 2011

December 21, 2011
December 27, 2011
December 2011
August 2013   (final data collection date for primary outcome measure)
Point prevalence abstinence from smoking [ Time Frame: 26 weeks from smoking quit date ] [ Designated as safety issue: No ]
We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.
Same as current
Complete list of historical versions of study NCT01501877 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Smoking Cessation Intervention for Diabetic Patients
Smoking Cessation Intervention for Diabetic Patients

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

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Smoking
  • Type 2 Diabetes
  • Behavioral: Acceptance and Commitment Therapy
    The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
  • Behavioral: Standard smoking cessation intervention
    Standard smoking cessation intervention based on clinical practice guidelines.
  • 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.
    Intervention: Behavioral: Acceptance and Commitment Therapy
  • 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.
    Intervention: Behavioral: Standard smoking cessation intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Susan E Ramsey, Ph.D. 4014447831 sramsey@lifespan.org
United States
 
NCT01501877
DA030532
Yes
Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Susan E. Ramsey, Ph.D. Rhode Island Hospital
Rhode Island Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP