Smoking Cessation Using Motivational Therapy and Varenicline

Philip Diaz

Status: Completed

Conditions: HIV Infections; Smoking

Treatments: Behavioral: Motivational Interview; Drug: Nicotine Replacement Therapy; Other: Biological Control; Drug: Varenicline tartrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00701896

2007H0173

R01HL090313 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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294 participants in 4 patient groups

Healthy Control - Non-smoking

Other group

Description:

Healthy Control arm with 51 subjects who are HIV negative and do not smoke

Treatment:

Other: Biological Control

Healthy Control - Smoker

Other group

Description:

Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.

Treatment:

Other: Biological Control

HIV Smoking Cessation Arm

Active Comparator group

Description:

Includes up to 365 subjects who are HIV positive and initiate smoking cessation

Treatment:

Drug: Varenicline tartrate

Drug: Nicotine Replacement Therapy

Motivational Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interview