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

NCT05873738 | Completed FDA Drug

• 1 other identifier: 3.171.692
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking Cessation; Brachial Flow Mediated Dilatation; Nicotine Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• FMD

  Flow mediated brachial artery dilatation

  12 months

Study Arms (2)

Group 1

Relapse

Drug: Nicotine replacement

Group 2

Smoking cessation

Drug: Nicotine replacement

Interventions

Nicotine replacement DRUG

Nicotine patches

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults HIV positive who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Fernandes Figueira: lead

Study Sites (1)

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 22210-080, Brazil

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: December 10, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)