CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 488 enrolled
Drug / intervention
Combination Therapy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02982772
NCT02982772N/ACompleted

Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)

dr. maria miguez·interventional·Posted Dec 5, 2016·Updated Oct 6, 2021

In Brief

A clinical study evaluating Combination Therapy and Standard Care Intervention for Smoking Cessation and HIV. Completed, enrolled 488 participants across 1 site.

Detailed Summary

The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsUniversity of Miami

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 5, 2016
Enrollment StartMay 1, 2016
Primary CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.6 years ago

Interventions

Combination Therapyother

Brief behavioral intervention The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.

Standard Care Interventionother

Brief Behavioral Intervention The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used. Standard Flavored Gums for 10 weeks