Electronic Cigarettes as a Harm Reduction Strategy Among People Living With HIV/AIDS

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): counseling + nicotine replacement therapies NRT (active comparator) and Counseling + Standardized Research E-cigarettes (SREC) (active comparator).

The registry classes the interventions as behavioral and other.

More on the Plan

People living with HIV/AIDS (PLWHA) are known to have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Current Combustible Cigarette (CC) smokers (more than 5 packs in a lifetime; smokes 4 or more days/week),. Smokes at least 10 cigarettes per day on days they smoke CC. Motivated to quit smoking (at least a 5 on a 10-point Likert scale). Must be able to provide consent. Agree to be randomized and followed-up with,.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: are pregnant (as determined by urine test) or breastfeeding (self-reported),; state diagnosis of any medical condition (angina/heart disease) precluding use of nicotine patch or gum, or by self-report in screening questionnaire; reporting using nrts or e-cigarettes or within the last 30 days.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2021-06-17 with completion listed for 2023-12-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Cigarettes per Day (CPD) (time frame: Visit 1 (week1), Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 6), Visit 5 (Week 8), Visit 6 (week 12)).

It also tracked 5 secondary outcomes, for example Assessing differences in nicotine withdrawal symptoms, Assessing differences in E-cigarette dependency, Assessing differences in nicotine use and Assessing differences in use of substance use.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.