Smoking Cessation Using Motivational Therapy and Varenicline

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Philip Diaz, The Ohio State University

ClinicalTrials.gov Identifier:

NCT00701896

First received: June 17, 2008

Last updated: April 20, 2015

Last verified: April 2015

History of Changes

Purpose

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.

Condition	Intervention
Smoking HIV Infections	Drug: Varenicline tartrate Drug: Nicotine Replacement Therapy Other: Biological Control Behavioral: Motivational Interview


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Smoking Cessation and the Natural History of HIV-Associated Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema HIV/AIDS Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To explore the effects of smoking cessation on the biology of alveolar macrophages obtained from HIV-seropositive individuals [ Time Frame: 48 Months ] [ Designated as safety issue: No ]


Estimated Enrollment:	365
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healthy Control - Non-smoking Healthy Control arm with 51 subjects who are HIV negative and do not smoke	Other: Biological Control No treatment intervention only information and procedures.
Healthy Control - Smoker Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.	Other: Biological Control No treatment intervention only information and procedures.
Active Comparator: HIV Smoking Cessation Arm Includes up to 365 subjects who are HIV positive and initiate smoking cessation	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
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	Behavioral: Motivational Interview 60 minute one-on-one Interview

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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: NCT00701896

Locations


United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Philip Diaz

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Philip T. Diaz, MD	Ohio State University

More Information


Responsible Party:	Philip Diaz, Director, Pulmonary Rehabilitation Services; Medical Director, Respiratory Therapy; Associate Director, General Clinical Research Center, The Ohio State University
ClinicalTrials.gov Identifier:	NCT00701896 History of Changes
Other Study ID Numbers:	2007H0173 R01HL090313
Study First Received:	June 17, 2008
Last Updated:	April 20, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:


HIV Positive Smokers Varenicline

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Varenicline	Nicotine Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2016

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