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

History of Changes

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:

MedlinePlus related topics: Anxiety HIV/AIDS Quitting Smoking Smoking

U.S. FDA Resources

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:

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 (Adult)
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 Mental Disorders Substance-Related Disorders Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 27, 2016

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