Smoking Treatment in HIV Clinical Care Settings

Nicotine Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297453
• Other study ID #: NIDA 09253-7
• Secondary ID: P50DA009253
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2006
• Last updated: June 25, 2012
• Start date: January 2006
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

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.
• 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
Participants receive a self-help manual and have access to a 10 nicotine replacement treatment.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7 day point prevalence biochemically verified abstinence rates		3, 6, 9, and 12 months following treatment initiation	No