Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

What Was Tested

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

Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up.

In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.

It had four arms (groups): Bupropion SR (active comparator), Nicotine Patch (active comparator), Placebo Patch and Placebo Pill (placebo comparator) and Delayed-quit control (no intervention).

Individuals were placed on both a placebo patch that were the same size as active patches given to the Nicotine Patch group and were also given placebo pills were the same size and identically packaged as the active pills (bupropion) given to the Bupropion SR group.

The registry classes the interventions as drug.

More on the Plan

Study sensitivity and accuracy will be maximized by using procedures designed to maximize abstinence and minimize study dropout.

The second aim is to characterize brain and psychological mechanisms by which BUP and TNP promote abstinence.

A secondary goal is to assess the ability of a battery of innovative brain and biobehavioral measures of attention and affect to predict relapse.

To achieve these goals, the effects of quitting smoking with or without the help of TNP and BUP will be assessed intensively across 66 days of abstinence.

Who Took Part

197 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence. Smokes at least 10 cigarettes per day for the three months prior to enrollment. Currently seeking treatment for nicotine dependence. Medically healthy on the basis of physical examination and medical history, vital signs,.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: current axis i diagnosis or current treatment with psychotropic medications within the three months prior to enrollment; history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders; currently seeking treatment for nicotine disorders.

How the Study Was Run

It was run as a randomized, factorial and double-blind 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.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2005-06 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit (time frame: Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit). Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence (time frame: Changes in log withdrawal symptoms from baseline through 66 days of abstinence).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 197 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.