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OpenTrials
Completed

NCT Number: NCT00701896

Smoking Cessation Using Motivational Therapy and Varenicline

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

varenicline tartrate

Drug

1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.

Other names: Chantix

Nicotine Replacement Therapy

Drug

Nicotine gum and nicotine patch

Biological Control

Other

No treatment intervention only information and procedures.

Motivational interview

Behavioral

60 minute one-on-one Interview

Primary outcomes

  1. To Determine the Safety of Varenicline in PLWH Who Smoke

    Time frame: 3 months

    To determine the safety and tolerability of varenicline compared to nicotine replacement

Secondary outcomes

  1. To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke

    Time frame: 12 months

    To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline

Sponsors and collaborators

Lead sponsor

Philip Diaz

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Smoking Cessation and the Natural History of HIV-Associated Emphysema

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2008
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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