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

This study has been completed.
Sponsor:
Collaborators:
Southern Methodist University
University of Houston
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Conall O'Cleirigh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01393301
First received: July 11, 2011
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Nicotine Dependence
Symptoms of Anxiety
HIV
Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Treatment for Smoking Cessation & Anxiety in People With HIV Phase 1

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: October 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01393301

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Southern Methodist University
University of Houston
National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: Conall O'Cleirigh, Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01393301     History of Changes
Other Study ID Numbers: R34DA031038-01A1  1R34DA031038-01A1 
Study First Received: July 11, 2011
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Nicotine dependence
Smoking, cessation
Quitting
Anxiety symptoms
Cognitive-behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 25, 2016