A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

Many people living with HIV (PLWH) smoke.

Smoking in these individuals is often undertreated.

It had six arms (groups): 12 wks NRT+CM / 12 wks NRT+CM (experimental), 12 wks NRT+CM/ 12 wks VAR or bupropion+CM (experimental), 12 wks NRT+CM/12 wks NRT+CM plus (experimental), 12 wks NRT/ 12 wks NRT (experimental) and 12 wks NRT/ 12 wks VAR or bupropion (experimental).

Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.

Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.

Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.

The registry classes the interventions as behavioral and drug.

More on the Plan

At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM).

At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide \[eCO\] or collateral verification) in both arms will receive 12 more weeks of the same treatment.

Who Took Part

The registry lists 323 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: \>= 18 years old. Receiving HIV care at Yale-New Haven Hospital, Bridgeport Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;. Have smoked \>= 100 cigarettes in lifetime;. Currently smokes some days or every day;. Smokes, on average, \>= 5 cigarettes per day;.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: using only non-cigarette nicotine products (i.e., e-cigs, juul, etc.);; currently using nrt, var, or bupropion (defined as use in the prior 7 days);; self-report or urine testing confirming pregnancy, nursing, or trying to conceive;.

How the Study Was Run

It was run as a randomized, sequential and open-label study.

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.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2020-07-27 with completion listed for 2024-10-24.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks, Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks, VACS Index 2.0 Score, CD4 Count and HIV Viral Load, Detectable.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 323 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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