Smoking Treatment of Prisoners | NCT00110630

Studies
Smoking Treatment of Prisoners

NCT00110630

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

250Actual

Phase

Phase 3

Conditions

Tobacco Use Cessation
Tobacco Use Disorder

Interventions

10-week smoking cessation group therapy combined with NicoDerm CQ

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K23-15774-2

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

May 11, 2005

First Submission Date that Met QC Criteria

May 10, 2005

First Posted Date

May 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Name	Type	Description	Arm Group Labels	Other Names
10-week smoking cessation group therapy combined with NicoDerm CQ	Behavioral

Measure	Description	Time Frame
smoking cessation

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Cropsey, Ph.D.	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D020340	Tobacco Use Cessation
D014029	Tobacco Use Disorder

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009538	Nicotine

Ancestor Terms

ID	Term
D012991	Solanaceous Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided