Motivation and Patch Treatment for HIV-Positive Smokers (Positive PATHS)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00551720
First received: October 30, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 30, 2007
October 30, 2007
January 1999
Not Provided
smoking cessation [ Time Frame: 6-months ]
Same as current
No Changes Posted
smoking cessation [ Time Frame: 2- and 4-months ]
Same as current
Not Provided
Not Provided
 
Motivation and Patch Treatment for HIV-Positive Smokers
Motivation and Patch Treatment for HIV-Positive Smokers

The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine patch, with the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the SC control treatment. All study participants were offered use of the nicotine patch.

Cigarette smoking is highly prevalent among HIV+ individuals, posing unique health risks, impacting HAART-therapy effectiveness, and possibly altering the course of the disease. To our knowledge, Motivation and Patch Treatment for HIV-Positive Individuals (Positive PATHS) was the first NIH-funded smoking cessation intervention designed to motivate HIV+ smokers to quit. Participants were referred by physicians at eight Immunology clinics in New England and randomized to receive either a brief, two-session intervention (Standard Care; SC) modeled on PHS guidelines, or a more intensive, four-session motivational counseling intervention (Motivational-Enhancement; ME). All physicians participating in the trial were trained in study eligibility criteria, as well as basic smoking cessation counseling strategies (based on the PHS guidelines). Interested individuals were then referred to the study, with a study researcher explaining the details of the study and obtaining informed consent. Participants were then assisted in completing baseline assessments via laptop computer, and then randomized to receive either a brief intervention (2-sessions) designed to reflect the standard of care in outpatient hospital settings and modeled on PHS guidelines (standard care; SC) or a more intensive (4-session) motivational counseling intervention (motivational enhancement; ME), with both interventions providing 8-weeks of nicotine replacement (patches; NRT) to those participants willing to set a quit date. Follow-up assessments, including biochemical verification of self-reported quitters (via carbon monoxide measurement) were conducted at 2, 4, and 6 months from baseline. This study is among the first to examine the health effects of a delivered smoking cessation intervention to an HIV+ population, with the results having implications for treatments in clinical care settings.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Smoking Cessation
  • Behavioral: Standard Care
    Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch
  • Behavioral: Motivational Enhancement
    Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
  • Experimental: Standard Care
    Intervention: Behavioral: Standard Care
  • Experimental: Motivational Enhancement
    Intervention: Behavioral: Motivational Enhancement
Lloyd-Richardson EE, Stanton CA, Papandonatos GD, Shadel WG, Stein M, Tashima K, Flanigan T, Morrow K, Neighbors C, Niaura R. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Addiction. 2009 Nov;104(11):1891-900. Epub 2009 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
444
December 2004
Not Provided

Inclusion Criteria:

  • Be receiving care for HIV at one of the participating immunology clinics
  • Be 18 years old or older
  • Be current (past 7 days) cigarette smoker
  • Speak English or Spanish

Exclusion Criteria:

  • Are pregnant or nursing
  • Have uncontrolled hypertension
  • Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help with quitting smoking
  • Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551720
R01 DA 12344
Yes
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Raymond Niaura, PhD Brown University-Butler Hospital
Study Director: Elizabeth Lloyd-Richardson, PhD Brown University/The Miriam Hospital
National Institute on Drug Abuse (NIDA)
October 2007

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