Smoking Treatment in HIV Clinical Care Settings

NCT ID: NCT00297453

Last Updated: 2012-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet

Individual counseling + nicotine replacement. 6 sessions across a 3 month period.

Group Type EXPERIMENTAL

Internet-based smoking treatment

Intervention Type BEHAVIORAL

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

Individual counseling plus nicotine replacement treatment.

Group Type EXPERIMENTAL

Individual Counseling

Intervention Type BEHAVIORAL

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

Self-help Manual plus nicotine replacment treatment.

Group Type ACTIVE_COMPARATOR

self-help

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

self-help

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Gary Humfleet

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Humfleet, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type DERIVED
PMID: 39868569 (View on PubMed)

Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.

Reference Type DERIVED
PMID: 39101506 (View on PubMed)

Other Identifiers

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P50DA009253

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA 09253-7

Identifier Type: -

Identifier Source: org_study_id

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