A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Yale University
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01106638
First received: April 19, 2010
Last updated: April 29, 2010
Last verified: April 2010

April 19, 2010
April 29, 2010
November 2009
March 2011   (final data collection date for primary outcome measure)
Three month point-prevalence abstinence from cigarettes [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106638 on ClinicalTrials.gov Archive Site
Three month continuous abstinence from cigarettes [ Time Frame: Three months post-intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking
  • HIV Infections
  • AIDS
  • Behavioral: Positively Smoke Free
    An eight session, group therapy intervention targeting smokers living with HIV/AIDS
  • Behavioral: Standard care
    Advice to quit, smoking cessation brochure, and offer of nicotine patches
  • Experimental: Intensive behavioral intervention
    Eight session, behavioral intervention targeting HIV-infected smokers
    Intervention: Behavioral: Positively Smoke Free
  • Active Comparator: Standard care
    Advice to quit, smoking cessation brochure, offer of nicotine patch
    Intervention: Behavioral: Standard care
Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
May 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infection
  • current cigarette smoker
  • high motivation to quit

Exclusion Criteria:

  • Pregnancy
  • breastfeeding
Both
18 Years and older
No
Contact: Jonathan Shuter, MD 718-920-7845 jshuter@montefiore.org
Contact: Eileen Dolce, PA 718-920-6528 edolce@montefiore.org
United States
 
NCT01106638
R21 DA023362
No
Jonathan Shuter, MD, Montefiore Medical Center
Montefiore Medical Center
  • Albert Einstein College of Medicine of Yeshiva University
  • Yale University
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
Montefiore Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP