Clinical trial NCT00551720: Motivation and Patch Treatment for HIV-positive Smokers
Official title: Motivation and Patch Treatment for HIV-positive Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Smoking Cessation
Keywords: HIV
HIV positive
AIDS
smoking cessation
smoking
smoking counseling
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-10-31
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine patch, with the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the SC control treatment. All study participants were offered use of the nicotine patch.

Detailed description: Cigarette smoking is highly prevalent among HIV+ individuals, posing unique health risks, impacting HAART-therapy effectiveness, and possibly altering the course of the disease. To our knowledge, Motivation and Patch Treatment for HIV-Positive Individuals (Positive PATHS) was the first NIH-funded smoking cessation intervention designed to motivate HIV+ smokers to quit. Participants were referred by physicians at eight Immunology clinics in New England and randomized to receive either a brief, two-session intervention (Standard Care; SC) modeled on PHS guidelines, or a more intensive, four-session motivational counseling intervention (Motivational-Enhancement; ME). All physicians participating in the trial were trained in study eligibility criteria, as well as basic smoking cessation counseling strategies (based on the PHS guidelines). Interested individuals were then referred to the study, with a study researcher explaining the details of the study and obtaining informed consent. Participants were then assisted in completing baseline assessments via laptop computer, and then randomized to receive either a brief intervention (2-sessions) designed to reflect the standard of care in outpatient hospital settings and modeled on PHS guidelines (standard care; SC) or a more intensive (4-session) motivational counseling intervention (motivational enhancement; ME), with both interventions providing 8-weeks of nicotine replacement (patches; NRT) to those participants willing to set a quit date. Follow-up assessments, including biochemical verification of self-reported quitters (via carbon monoxide measurement) were conducted at 2, 4, and 6 months from baseline. This study is among the first to examine the health effects of a delivered smoking cessation intervention to an HIV+ population, with the results having implications for treatments in clinical care settings.

Eligibility criteria: Inclusion Criteria:

* Be receiving care for HIV at one of the participating immunology clinics
* Be 18 years old or older
* Be current (past 7 days) cigarette smoker
* Speak English or Spanish

Exclusion Criteria:

* Are pregnant or nursing
* Have uncontrolled hypertension
* Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help with quitting smoking
* Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch

Primary outcomes:
measure: smoking cessation
timeFrame: 6-months
Secondary outcomes:
measure: smoking cessation
timeFrame: 2- and 4-months
Other outcomes:
Locations:
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources, Inc.
state: Massachusetts
city: New Bedford
country: United States
facility: Greater New Bedford Community Center
state: Massachusetts
city: Pawtucket
country: United States
facility: Hope Center for HIV Care, Memorial Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital HIV Clinic
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital Immunology Clinic
state: Rhode Island
Study officials:
affiliation: Brown University-Butler Hospital
name: Raymond Niaura, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University/The Miriam Hospital
name: Elizabeth Lloyd-Richardson, PhD
role: STUDY_DIRECTOR
References:
citation: Lloyd-Richardson EE, Stanton CA, Papandonatos GD, Shadel WG, Stein M, Tashima K, Flanigan T, Morrow K, Neighbors C, Niaura R. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Addiction. 2009 Nov;104(11):1891-900. doi: 10.1111/j.1360-0443.2009.02623.x. Epub 2009 Aug 28.