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Smoking Treatment in HIV Clinical Care Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00297453
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : June 27, 2012
Information provided by (Responsible Party):

February 24, 2006
February 28, 2006
June 27, 2012
January 2006
January 2011   (Final data collection date for primary outcome measure)
7 day point prevalence biochemically verified abstinence rates [ Time Frame: 3, 6, 9, and 12 months following treatment initiation ]
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Complete list of historical versions of study NCT00297453 on ClinicalTrials.gov Archive Site
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Smoking Treatment in HIV Clinical Care Settings
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The study is designed to evaluate and compare the efficacy and cost effectiveness of 3 smoking cessation treatments with HIV-positive cigarette smokers. The treatments include face-to-face individual counseling, a computer-Internet-based self-help treatment and a self-help manual treatment.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nicotine Dependence
  • Behavioral: Internet-based smoking treatment
    All participants have access to an Internet-based self-help intervention that includes social support through message boards. All participants have access to 10 weeks of nicotine replacement treatment.
  • Behavioral: Individual Counseling
    Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
  • Behavioral: self-help
    Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.
  • Experimental: Internet
    Individual counseling + nicotine replacement. 6 sessions across a 3 month period.
    Intervention: Behavioral: Internet-based smoking treatment
  • Experimental: Counseling
    Individual counseling plus nicotine replacement treatment.
    Intervention: Behavioral: Individual Counseling
  • Active Comparator: Self-Help
    Self-help Manual plus nicotine replacment treatment.
    Intervention: Behavioral: self-help
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • 18 years or older
  • smoking "most days" during the past month
  • must be able to read English

Exclusion Criteria:

  • any contraindications for over-the-counter nicotine replacement treatment
  • active psychotic symptoms
  • severe cognitive deficits/dementia
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NIDA 09253-7
P50DA009253 ( U.S. NIH Grant/Contract )
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Gary Humfleet, University of California, San Francisco
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: Gary Humfleet, Ph.D. University of California, San Francisco
University of California, San Francisco
June 2012

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