Back to resultsSmoking Treatment in HIV Clinical Care Settings
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Internet-based smoking treatment
Individual Counseling
self-help
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence
Eligibility 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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Internet
Counseling
Self-Help
Arm Description
Individual counseling + nicotine replacement. 6 sessions across a 3 month period.
Individual counseling plus nicotine replacement treatment.
Self-help Manual plus nicotine replacment treatment.
Outcomes
Primary Outcome Measures
7 day point prevalence biochemically verified abstinence rates
Secondary Outcome Measures
Full Information
NCT ID
NCT00297453
First Posted
February 24, 2006
Last Updated
June 25, 2012
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00297453
Brief Title
Smoking Treatment in HIV Clinical Care Settings
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet
Arm Type
Experimental
Arm Description
Individual counseling + nicotine replacement. 6 sessions across a 3 month period.
Arm Title
Counseling
Arm Type
Experimental
Arm Description
Individual counseling plus nicotine replacement treatment.
Arm Title
Self-Help
Arm Type
Active Comparator
Arm Description
Self-help Manual plus nicotine replacment treatment.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based smoking treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Counseling
Intervention Description
Six individual counseling sessions are provided over a 12 week treatment period. Participants also have access to a 10-week nicotine replacement treatment.
Intervention Type
Behavioral
Intervention Name(s)
self-help
Intervention Description
Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.
Primary Outcome Measure Information:
Title
7 day point prevalence biochemically verified abstinence rates
Time Frame
3, 6, 9, and 12 months following treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Humfleet, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
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Smoking Treatment in HIV Clinical Care Settings
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