Smoking Treatment in HIV Clinical Care Settings - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00297453

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 III

MedlinePlus related topics: AIDS Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	280
Study Start Date:	January 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Internet: Experimental 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.
Counseling: Experimental 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.
Self-Help: Active Comparator 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

Contacts

Contact: Gary Humfleet, Ph.D.

415-476-7674

ghumfleet@lppi.ucsf.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Gary Humfleet, Ph.D.

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Gary Humfleet, Ph.D.

University of California, San Francisco

More Information

Responsible Party:	University of California, San Francisco ( Gary Humfleet, Ph.D. )
Study ID Numbers:	NIDA 09253-7
Study First Received:	February 24, 2006
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00297453
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
HIV Infections

Tobacco Use Disorder
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 15, 2009