Combination Medications vs. Patch Alone for Medically-Ill Smokers

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Nicotine patch, nicotine inhaler, bupropion.

Nicotine patch.

The registry classes the interventions as drug.

More on the Plan

Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).

Who Took Part

The registry lists 127 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: Currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO)). 18 years or older. Interested in quitting within the next 30 days.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications; unable to give consent.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2005-09 with completion listed for 2007-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Tobacco use abstinence (time frame: 26 week).

It also tracked 3 secondary outcomes, for example Time to first relapse, Duration of medication use and Adverse clinical events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 127 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.