Smoking Cessation Using Motivational Therapy and Varenicline

Not Applicable

Completed

• Conditions: Smoking; HIV Infections
• Interventions: Behavioral: Motivational Interview; Other: Biological Control; Drug: Varenicline tartrate; Drug: Nicotine Replacement Therapy

• Registration Number: NCT00701896
• Lead Sponsor: Philip Diaz

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-10-03
• Primary Completion: 2013-04-20
• Study Completion: 2013-06-20
• Status Verified: 2020-12
• Results First Submitted: 2020-12-18
• Results First Submitted QC: 2020-12-18
• Last Update Submitted: 2020-12-18
• Results First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Motivational Intervention	Motivational Interview	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
Healthy Control - Non-smoking	Biological Control	Healthy Control arm with 51 subjects who are HIV negative and do not smoke
Healthy Control - Smoker	Biological Control	Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
HIV Smoking Cessation Arm	Varenicline tartrate	Includes up to 365 subjects who are HIV positive and initiate smoking cessation
HIV Smoking Cessation Arm	Nicotine Replacement Therapy	Includes up to 365 subjects who are HIV positive and initiate smoking cessation

Primary Outcome Measures

Name	Time	Method
To Determine the Safety of Varenicline in PLWH Who Smoke	3 months	To determine the safety and tolerability of varenicline compared to nicotine replacement

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States