Smoking Cessation Using Motivational Therapy and Varenicline
Primary Purpose
Smoking, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varenicline tartrate
Nicotine Replacement Therapy
Biological Control
Motivational Interview
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring HIV, Positive, Smokers, Varenicline
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and older;
- diagnosis of HIV;
- self-reported smoking on a daily basis;
- provide informed written consent
Exclusion Criteria:
- persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
- unable to understand spoken English
- age less than 18 years.
- pregnant women
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Active Comparator
Experimental
Arm Label
Healthy Control - Non-smoking
Healthy Control - Smoker
HIV Smoking Cessation Arm
Motivational Intervention
Arm Description
Healthy Control arm with 51 subjects who are HIV negative and do not smoke
Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
Includes up to 365 subjects who are HIV positive and initiate smoking cessation
Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention
Outcomes
Primary Outcome Measures
To Determine the Safety of Varenicline in PLWH Who Smoke
To determine the safety and tolerability of varenicline compared to nicotine replacement
Secondary Outcome Measures
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline
Full Information
NCT ID
NCT00701896
First Posted
June 17, 2008
Last Updated
December 18, 2020
Sponsor
Philip Diaz
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00701896
Brief Title
Smoking Cessation Using Motivational Therapy and Varenicline
Official Title
Smoking Cessation and the Natural History of HIV-Associated Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2008 (Actual)
Primary Completion Date
April 20, 2013 (Actual)
Study Completion Date
June 20, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Diaz
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
Detailed Description
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, HIV Infections
Keywords
HIV, Positive, Smokers, Varenicline
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control - Non-smoking
Arm Type
Other
Arm Description
Healthy Control arm with 51 subjects who are HIV negative and do not smoke
Arm Title
Healthy Control - Smoker
Arm Type
Other
Arm Description
Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
Arm Title
HIV Smoking Cessation Arm
Arm Type
Active Comparator
Arm Description
Includes up to 365 subjects who are HIV positive and initiate smoking cessation
Arm Title
Motivational Intervention
Arm Type
Experimental
Arm Description
Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention
Intervention Type
Drug
Intervention Name(s)
Varenicline tartrate
Other Intervention Name(s)
Chantix
Intervention Description
1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy
Intervention Description
Nicotine gum and nicotine patch
Intervention Type
Other
Intervention Name(s)
Biological Control
Intervention Description
No treatment intervention only information and procedures.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
60 minute one-on-one Interview
Primary Outcome Measure Information:
Title
To Determine the Safety of Varenicline in PLWH Who Smoke
Description
To determine the safety and tolerability of varenicline compared to nicotine replacement
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
Description
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and older;
diagnosis of HIV;
self-reported smoking on a daily basis;
provide informed written consent
Exclusion Criteria:
persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
unable to understand spoken English
age less than 18 years.
pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T. Diaz, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Cessation Using Motivational Therapy and Varenicline
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