Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

Currently one in five high school students smokes.

Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems.

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (placebo comparator).

Nicotine patch.

Nicotine gum.

Folic acid.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Among adolescents, the short-term health effects of smoking include damage to the respiratory system, addiction to nicotine, and the associated risk of other drug use.

Adolescents are at greater risk for long-term health problems because most young people who smoke regularly continue to smoke throughout adulthood.

This open-label study will last a total of 6 weeks.

Baseline measurements will be taken twice a week at study visits for the first two weeks to assess vital signs and smoking behavior.

Who Took Part

128 actual participants took part.

It was open to people of any sex aged from 13 years up to 18 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: At least 6 months of daily cigarette smoking. No use of other tobacco products. Not currently using medications to quit smoking.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: people for whom use of nicotine replacement therapy or bupropion is medically inadvisable; history of emotional problems (as assessed by the adolescent symptoms inventory) within 6 months prior to enrollment; currently taking medications that may react with one of the treatment medications.

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.

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

It started in 2002-04 with completion listed for 2004-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Smoking cessation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 128 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.