Smoking Cessation Using Motivational Therapy and Varenicline

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Smoking Cessation and the Natural History of HIV-Associated Emphysema

Conditions
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Smoking, HIV Infections

Intervention / Treatment
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* Drug: Varenicline tartrate
* Drug: Nicotine Replacement Therapy
* Other: Biological Control
* Behavioral: Motivational Interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Control - Non-smoking<br>Healthy Control arm with 51 subjects who are HIV negative and do not smoke | Other: Biological Control<br>* No treatment intervention only information and procedures.<br>|
| Other: Healthy Control - Smoker<br>Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. | Other: Biological Control<br>* No treatment intervention only information and procedures.<br>|
| Active Comparator: HIV Smoking Cessation Arm<br>Includes up to 365 subjects who are HIV positive and initiate smoking cessation | Drug: Varenicline tartrate<br>* 1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.<br>* Other names: Chantix;Drug: Nicotine Replacement Therapy<br>* Nicotine gum and nicotine patch<br>|
| Experimental: Motivational Intervention<br>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<br>* 60 minute one-on-one Interview<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Safety of Varenicline in PLWH Who Smoke | To determine the safety and tolerability of varenicline compared to nicotine replacement | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Positive, Smokers, Varenicline