Smoking Cessation Intervention for Diabetic Patients
SSTOP
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is designed to develop and test a smoking cessation intervention for smokers with Type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 12, 2017
April 1, 2017
4.3 years
December 21, 2011
April 10, 2017
Conditions
Keywords
Outcome Measures
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.
26 weeks from smoking quit date
Study Arms (2)
Distress Tolerance
EXPERIMENTALAcceptance 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
ACTIVE COMPARATORStandard 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.
Interventions
The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
Standard smoking cessation intervention based on clinical practice guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan E. Ramsey, Ph.D.
Rhode Island Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 30, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
April 12, 2017
Record last verified: 2017-04