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Smoking Cessation Using Motivational Therapy and Varenicline

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ClinicalTrials.gov Identifier: NCT00701896
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Smoking HIV Infections Drug: Varenicline tartrate Drug: Nicotine Replacement Therapy Other: Biological Control Behavioral: Motivational Interview Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Study Start Date : June 2008
Actual Primary Completion Date : April 20, 2013
Actual Study Completion Date : June 20, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ]

Secondary Outcome Measures :
  1. 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 ]
  2. To explore the effects of smoking cessation on the biology of alveolar macrophages obtained from HIV-seropositive individuals [ Time Frame: 48 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age and older;
  2. diagnosis of HIV;
  3. self-reported smoking on a daily basis;
  4. provide informed written consent

Exclusion Criteria:

  1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
  2. unable to understand spoken English
  3. age less than 18 years.
  4. pregnant women
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Philip Diaz, The 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
Nicotine
 Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action