Smoking Cessation Intervention for Diabetic Patients

NCT ID: NCT01501877

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Smoking; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Standard smoking cessation intervention

Intervention Type: BEHAVIORAL

Standard smoking cessation intervention based on clinical practice guidelines.

Interventions

Acceptance and Commitment Therapy

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

Intervention Type: BEHAVIORAL

Standard smoking cessation intervention

Standard smoking cessation intervention based on clinical practice guidelines.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan E. Ramsey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

DA030532

Identifier Type: -

Identifier Source: org_study_id