Smoking Treatment of Prisoners (STOP)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00110630
First received: May 11, 2005
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Tobacco Use Cessation
Tobacco Use Disorder
Behavioral: 10-week smoking cessation group therapy combined with NicoDerm CQ
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Treatment of Prisoners: Project "STOP"

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • smoking cessation [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: June 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110630

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Principal Investigator: Karen Cropsey, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Karen Cropsey, Univeristy of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00110630     History of Changes
Other Study ID Numbers: NIDA-15774-2, K23-15774-2
Study First Received: May 11, 2005
Last Updated: September 29, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014