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

June 17, 2008
June 4, 2013
June 2008
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00701896 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking
  • HIV Infections
  • 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
  • Other: Biological Control
    No treatment intervention only information and procedures.
  • Behavioral: Motivational Interview
    60 minute one-on-one Interview
  • Healthy Control - Non-smoking
    Healthy Control arm with 51 subjects who are HIV negative and do not smoke
    Intervention: Other: Biological Control
  • Healthy Control - Smoker
    Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
    Intervention: Other: Biological Control
  • Active Comparator: HIV Smoking Cessation Arm
    Includes up to 365 subjects who are HIV positive and initiate smoking cessation
    Interventions:
    • Drug: Varenicline tartrate
    • Drug: Nicotine Replacement Therapy
  • 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
    Intervention: Behavioral: Motivational Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
365
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT00701896
2007H0173, R01HL090313
Yes
Philip Diaz, The Ohio State University
Philip Diaz
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Philip T. Diaz, MD Ohio State University
Ohio State University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP