Smoking Cessation Using Motivational Therapy and Varenicline

• 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 ]

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.

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.

• Smoking
• HIV Infections

• 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
• Other: Biological Control
  No treatment intervention only information and procedures.
• Behavioral: Motivational Interview
  60 minute one-on-one Interview

• Healthy Control - Non-smoking
  Healthy Control arm with 51 subjects who are HIV negative and do not smoke
  Intervention: Other: Biological Control
• Healthy Control - Smoker
  Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
  Intervention: Other: Biological Control
• Active Comparator: HIV Smoking Cessation Arm
  Includes up to 365 subjects who are HIV positive and initiate smoking cessation
  Interventions:

  • Drug: Varenicline tartrate
  • Drug: Nicotine Replacement Therapy
• 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
  Intervention: Behavioral: Motivational Interview

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