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. Identifier: NCT00297453
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : June 27, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Gary Humfleet, University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Internet-based smoking treatment Behavioral: Individual Counseling Behavioral: self-help Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2006
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 7 day point prevalence biochemically verified abstinence rates [ Time Frame: 3, 6, 9, and 12 months following treatment initiation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297453

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: Gary Humfleet, Ph.D. University of California, San Francisco

Responsible Party: Gary Humfleet, Associate Professor, University of California, San Francisco Identifier: NCT00297453     History of Changes
Other Study ID Numbers: NIDA 09253-7
P50DA009253 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: June 27, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action