Smoking Cessation Using Motivational Therapy and Varenicline

This study is ongoing, but not recruiting participants.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University Identifier:
First received: June 17, 2008
Last updated: April 20, 2015
Last verified: April 2015
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
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:

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00701896

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Philip Diaz
National Heart, Lung, and Blood Institute (NHLBI)
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 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:

Additional relevant MeSH terms:
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Physiological Effects of Drugs processed this record on May 26, 2016