Smoking Treatment in HIV Clinical Care Settings

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Behavioral: Internet-based smoking treatment
Behavioral: Individual Counseling
Behavioral: self-help
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 7 day point prevalence biochemically verified abstinence rates [ Time Frame: 3, 6, 9, and 12 months following treatment initiation ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: January 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet
Individual counseling + nicotine replacement. 6 sessions across a 3 month period.
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.
Experimental: Counseling
Individual counseling plus 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.
Active Comparator: Self-Help
Self-help Manual plus nicotine replacment treatment.
Behavioral: self-help
Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297453

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Gary Humfleet, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Gary Humfleet, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00297453     History of Changes
Other Study ID Numbers: NIDA 09253-7, P50DA009253
Study First Received: February 24, 2006
Last Updated: June 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014