Combination Nicotine Replacement for Alcoholic Smokers

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The 175 patients will be divided into two groups.

It had two arms (groups): Nicotine patch plus placebo gum (placebo comparator) and Nicotine patch plus active gum (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

96 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: Males and females at least 18 years old. Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking. Have a current desire to stop smoking and stop drinking. Willing to complete followup assessments up to 12 months after treatment. One person per household.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: allergy to nicotine patch or nicotine gum; weigh less than 100 pounds; use other nicotine products, such as cigars, pipes or smokeless tobacco.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2002-08 with completion listed for 2006-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 6 Month Smoking Abstinence (time frame: 6 months after smoking quit date). 12 Month Smoking Abstinence (time frame: 12 months after smoking quit date).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 96 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.