Back to resultsSmoking Treatment of Prisoners (STOP)
Primary Purpose
Tobacco Use Cessation, Tobacco Use Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
10-week smoking cessation group therapy combined with NicoDerm CQ
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Cessation focused on measuring nicotine dependence
Eligibility Criteria
Inclusion Criteria: 1) current smoker and (2) seeking group treatment to quit smoking. Exclusion Criteria: (1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.
Sites / Locations
- Virginia Commonwealth University
Outcomes
Primary Outcome Measures
smoking cessation
Secondary Outcome Measures
Full Information
NCT ID
NCT00110630
First Posted
May 11, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00110630
Brief Title
Smoking Treatment of Prisoners
Acronym
STOP
Official Title
Smoking Treatment of Prisoners: Project "STOP"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy combined with NicoDerm CQ for smoking cessation among female prisoners.
Detailed Description
This is a randomized controlled trial utilizing a wait-list control group to examine 10-week group therapy and nicotine replacement compared to wait-list for smoking cessation among female prisoners.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Tobacco Use Disorder
Keywords
nicotine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
10-week smoking cessation group therapy combined with NicoDerm CQ
Primary Outcome Measure Information:
Title
smoking cessation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) current smoker and (2) seeking group treatment to quit smoking.
Exclusion Criteria:
(1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Cropsey, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Treatment of Prisoners
We'll reach out to this number within 24 hrs