Smoking Cessation Using Motivational Therapy and Varenicline

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00701896
First received: June 17, 2008
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Smoking
HIV Infections
Drug: Varenicline tartrate
Drug: Nicotine Replacement Therapy
Other: Biological Control
Behavioral: Motivational Interview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 48 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effects of smoking cessation on the course of lung function decline, the prevalence of respiratory symptoms and the occurrence/progression of emphysema in a cohort of HIV-seropositive individuals. [ Time Frame: 48 Months ] [ Designated as safety issue: No ]
  • To explore the effects of smoking cessation on the biology of alveolar macrophages obtained from HIV-seropositive individuals [ Time Frame: 48 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 365
Study Start Date: June 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701896

Contacts
Contact: Philip T. T. Diaz, MD 614-293-4978 philip.diaz@osumc.edu
Contact: Janice E. Drake, CRTT 614-366-2287 janice.drake@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice E. Drake, CRTT    614-366-2287    janice.drake@osumc.edu   
Contact: Sharon Cheung, BS    614-366-2258    sharon.cheung@osumc.edu   
Sponsors and Collaborators
Philip Diaz
Investigators
Principal Investigator: Philip T. Diaz, MD Ohio State University
  More Information

No publications provided

Responsible Party: Philip Diaz, Director, Pulmonary Rehabilitation Services; Medical Director, Respiratory Therapy; Associate Director, General Clinical Research Center, The Ohio State University
ClinicalTrials.gov Identifier: NCT00701896     History of Changes
Other Study ID Numbers: 2007H0173, R01HL090313
Study First Received: June 17, 2008
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
HIV
Positive
Smokers
Varenicline

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014