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Smoking Treatment in HIV Clinical Care Settings

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Gary Humfleet, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00297453
First received: February 24, 2006
Last updated: June 25, 2012
Last verified: June 2012
History of Changes

February 24, 2006
June 25, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00297453 on ClinicalTrials.gov Archive Site
Not Provided
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Smoking Treatment in HIV Clinical Care Settings
Not Provided

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297453
NIDA 09253-7, P50DA009253
No
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