Smoking Cessation Using Motivational Therapy and Varenicline
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00701896 |
Recruitment Status
:
Completed
First Posted
: June 19, 2008
Last Update Posted
: February 13, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking HIV Infections | Drug: Varenicline tartrate Drug: Nicotine Replacement Therapy Other: Biological Control Behavioral: Motivational Interview | Not Applicable |
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 |
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
|
- To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Philip T. Diaz, MD | Ohio State University |
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 |