Smoking Cessation Using Motivational Therapy and Varenicline

Tracking Information
First Submitted Date ICMJE	June 17, 2008
First Posted Date ICMJE	June 19, 2008
Last Update Posted Date	February 13, 2017
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	April 20, 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 18, 2008)	To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00701896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 18, 2008)	To examine the effects of smoking cessation on the course of lung function decline, the prevalence of respiratory symptoms and the occurrence/progression of emphysema in a cohort of HIV-seropositive individuals. [ Time Frame: 48 Months ]; To explore the effects of smoking cessation on the biology of alveolar macrophages obtained from HIV-seropositive individuals [ Time Frame: 48 Months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Smoking Cessation Using Motivational Therapy and Varenicline
Official Title ICMJE	Smoking Cessation and the Natural History of HIV-Associated Emphysema
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Smoking; HIV Infections
Intervention ICMJE	Drug: Varenicline tartrate 1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12. Other Name: Chantix; Drug: Nicotine Replacement Therapy Nicotine gum and nicotine patch; Other: Biological Control No treatment intervention only information and procedures.; Behavioral: Motivational Interview 60 minute one-on-one Interview
Study Arms	Healthy Control - Non-smoking Healthy Control arm with 51 subjects who are HIV negative and do not smoke Intervention: Other: Biological Control; Healthy Control - Smoker Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. Intervention: Other: Biological Control; Active Comparator: HIV Smoking Cessation Arm Includes up to 365 subjects who are HIV positive and initiate smoking cessation Interventions: Drug: Varenicline tartrate Drug: Nicotine Replacement Therapy; Experimental: Motivational Intervention 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: Behavioral: Motivational Interview
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 10, 2017)	368
Original Estimated Enrollment ICMJE; (submitted: June 18, 2008)	365
Actual Study Completion Date	June 20, 2013
Actual Primary Completion Date	April 20, 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00701896
Other Study ID Numbers ICMJE	2007H0173; R01HL090313 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Philip Diaz, The Ohio State University
Study Sponsor ICMJE	Philip Diaz
Collaborators ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Investigators ICMJE	Principal Investigator: Philip T. Diaz, MD Ohio State University
PRS Account	Ohio State University
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP