NCT00110630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 11, 2005

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2008

Enrollment Period

2.3 years

First QC Date

May 11, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use CessationTobacco Use Disorder

Keywords

nicotine dependence

Outcome Measures

Primary Outcomes (1)

  • smoking cessation

Interventions

10-week smoking cessation group therapy combined with NicoDerm CQBEHAVIORAL

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) current smoker and (2) seeking group treatment to quit smoking.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Karen Cropsey, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 11, 2005

First Posted

May 11, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 12, 2017

Record last verified: 2008-09

Locations

US(1)