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CompletedNCT01501877SSTOPUpdated Apr 12, 2017

Smoking Cessation Intervention for Diabetic Patients

An interventional study of Acceptance and Commitment Therapy and Standard smoking cessation intervention in Smoking and Type 2 Diabetes, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-04-12.

Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Smoking
  • Type 2 Diabetes

Keywords

  • Smoking
  • Type 2 Diabetes
  • Smoking cessation
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralAcceptance and Commitment Therapy

    The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.

  • BehavioralStandard smoking cessation intervention

    Standard smoking cessation intervention based on clinical practice guidelines.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 26 weeks from smoking quit date

07

Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01501877
Lead sponsor
Rhode Island Hospital
Responsible party
Sponsor
First posted
Dec 30, 2011
Start date
Dec 2011
Primary completion
Apr 2016
Completion
Jun 2016
Last update
Apr 12, 2017

Study contacts

Susan E. Ramsey, Ph.D.
principal investigator · Rhode Island Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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