Smoking Cessation Using Motivational Therapy and Varenicline

Smoking Cessation and the Natural History of HIV-Associated Emphysema

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Smoking
• Intervention / Treatment: Other: Biological Control; Drug: Varenicline tartrate; Drug: Nicotine Replacement Therapy; Behavioral: Motivational Interview

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 Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Control - Non-smoking; Healthy Control arm with 51 subjects who are HIV negative and do not smoke	Other: Biological Control; No treatment intervention only information and procedures.
Other: Healthy Control - Smoker; Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.	Other: Biological Control; No treatment intervention only information and procedures.
Active Comparator: HIV Smoking Cessation Arm; Includes up to 365 subjects who are HIV positive and initiate smoking cessation	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 Names: Chantix; Drug: Nicotine Replacement Therapy; Nicotine gum and nicotine patch
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	Behavioral: Motivational Interview; 60 minute one-on-one Interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Philip Diaz
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Philip T. Diaz, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2008
• Primary Completion (Actual): April 20, 2013
• Study Completion (Actual): June 20, 2013

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 18, 2008
• First Posted (Estimate): June 19, 2008

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Varenicline; Smokers; Positive
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Varenicline
• Other Study ID Numbers: 2007H0173; R01HL090313 (U.S. NIH Grant/Contract)