Smoking Cessation Clinical Trial
Official title:
Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.
NCT number | NCT05873738 |
Other study ID # | 3.171.692 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 10, 2019 |
Est. completion date | April 15, 2023 |
Verified date | May 2023 |
Source | Instituto Fernandes Figueira |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 115 |
Est. completion date | April 15, 2023 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Nacional de Infectologia Evandro Chagas | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Instituto Fernandes Figueira |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FMD | Flow mediated brachial artery dilatation | 12 months |
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