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NCT00110630 Clinical Trial

Smoking Treatment of Prisoners

Tobacco Use Disorder Clinical Trial

— STOP  

Official title:
Smoking Treatment of Prisoners: Project "STOP"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00110630
Other study ID # NIDA-15774-2
Secondary ID K23-15774-2
Status Completed
Phase Phase 3
First received May 11, 2005
Last updated January 11, 2017
Start date June 2005
Est. completion date September 2007

Study information
Verified date September 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• 10-week smoking cessation group therapy combined with NicoDerm CQ

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary smoking cessation No
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