Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1 (Project Quit)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Southern Methodist University
University of Houston
Information provided by (Responsible Party):
Conall O'Cleirigh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01393301
First received: July 11, 2011
Last updated: February 24, 2012
Last verified: July 2011

July 11, 2011
February 24, 2012
October 2011
October 2012   (final data collection date for primary outcome measure)
Treatment Acceptability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The investigators will use the Treatment CEQ, a 6-item measure, to assess treatment credibility and expectancy for participants between their baseline assessment and 6-month follow-up assessment. The investigators will administer the scale after the first treatment session. Acceptability will also be evaluated on the basis of participant retention, which will be considered favorable acceptability based on retention of 80% or greater of participants. Participants' self-report of their reactions to the intervention and study participation will be assessed through a qualitative exit interview.
Same as current
Complete list of historical versions of study NCT01393301 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1
Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1

This is the 1-year initial phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment.

This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The 1-year initial phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be done with a small group of individuals (N = 12). This phase will be used to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Nicotine Dependence
  • Symptoms of Anxiety
  • HIV
Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety
Cognitive-behavioral therapy for smoking cessation, cognitive behavioral therapy for anxiety, nicotine replacement therapy (nicotine patch)
Other Name: START
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years old
  • Informed consent
  • Daily smoker
  • Motivated to quit smoking
  • Anxiety symptom elevation

Exclusion Criteria:

  • Use of other tobacco products
  • Untreated or unstable psychiatric disorders
  • Current use of cognitive-behavioral therapy or medication for smoking cessation treatment
  • Cognitive-behavioral therapy for anxiety within the past year
  • Insufficient command of English
Both
18 Years to 65 Years
No
Contact: Conall O'Cleirigh, Ph.D. 617-643-0385 cocleirigh@partners.org
Contact: Jesse Kosiba, BA 617-724-0637
United States
 
NCT01393301
R34 DA031038-01A1, 1R34DA031038-01A1
Yes
Conall O'Cleirigh, Massachusetts General Hospital
Massachusetts General Hospital
  • Southern Methodist University
  • University of Houston
Not Provided
Massachusetts General Hospital
July 2011

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