Smoking Cessation Using Motivational Therapy and Varenicline
This study is currently recruiting participants.
Verified October 2012 by Ohio State University
Sponsor:
Philip Diaz
Collaborator:
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00701896
First received: June 17, 2008
Last updated: October 24, 2012
Last verified: October 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701896
Contacts
| Contact: Philip T. T. Diaz, MD | 614-293-4978 | philip.diaz@osumc.edu |
| Contact: Janice E. Drake, CRTT | 614-366-2287 | janice.drake@osumc.edu |
Locations
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Janice E. Drake, CRTT 614-366-2287 janice.drake@osumc.edu | |
| Contact: Sharon Cheung, BS 614-366-2258 sharon.cheung@osumc.edu | |
Sponsors and Collaborators
Philip Diaz
Investigators
| Principal Investigator: | Philip T. Diaz, MD | Ohio State University |
More Information
No publications provided
| 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: | October 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
HIV Positive Smokers Varenicline |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Smoking Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Habits Nicotine Nicotine polacrilex |
Varenicline Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013