Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

NCT ID: NCT05873738

Last Updated: 2023-05-24

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

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-04-15

Brief Summary

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The study was carried out within a large, urban prospective cohort of PLHIV at the Instituto Nacional de Infectologia Evandro Chagas (INI). Located in Rio de Janeiro, Brazil, INI is a national public referral center for PLWHA receiving primary care since 1998. From December 2019, adults who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy were enrolled by active site searching

Detailed Description

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Conditions

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Smoking Cessation Brachial Flow Mediated Dilatation Nicotine Replacement Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Relapse

Nicotine replacement

Intervention Type DRUG

Nicotine patches

Group 2

Smoking cessation

Nicotine replacement

Intervention Type DRUG

Nicotine patches

Interventions

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Nicotine replacement

Nicotine patches

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* individuals were deemed as regular smokers, defined as the consumption of one or more pack (20 cigarettes) per week in the past 6 months, and expired carbon monoxide (CO) measurement \> 10 ppm at the screening visit.

Exclusion Criteria

* previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Fernandes Figueira

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rodrigo de Carvalho Moreira

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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3.171.692

Identifier Type: -

Identifier Source: org_study_id

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