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

Completed

• Conditions: Smoking Cessation; Nicotine Replacement Therapy; Brachial Flow Mediated Dilatation
• Interventions: Drug: Nicotine replacement

• Registration Number: NCT05873738
• Lead Sponsor: Instituto Fernandes Figueira

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-12-10
• Primary Completion: 2022-04-15
• Study Completion: 2023-04-15
• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Nicotine replacement	Relapse
Group 2	Nicotine replacement	Smoking cessation

Primary Outcome Measures

Name	Time	Method
FMD	12 months	Flow mediated brachial artery dilatation

Trial Locations

Locations (1)

Instituto Nacional de Infectologia Evandro Chagas; 🇧🇷 Rio de Janeiro, Brazil