Smoking Cessation Using Motivational Therapy and Varenicline

HIV Infections Clinical Trial

Official title:

Smoking Cessation and the Natural History of HIV-Associated Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701896
• Other study ID #: 2007H0173
• Secondary ID: R01HL090313
• Status: Completed
• Phase: N/A
• Start date: October 3, 2008
• Est. completion date: June 20, 2013

Study information

• Verified date: December 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: June 20, 2013
• Est. primary completion date: April 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Philip Diaz	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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