Targeted Interventions for Weight-Concerned Smokers

What Was Tested

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

Weight gain after quitting smoking is an important barrier to treatment for many smokers.

It had two arms (groups): Naltrexone, Transdermal Nicotine (experimental) and Placebo Naltrexone, Transdermal Nicotine (placebo comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date.

Naltrexone study medication will be started a week before their quit date and continued through the six-month period.

Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.

A follow-up appointment is completed at 12 months after participants' quit date.

Who Took Part

172 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: 1\. Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants. 2\. Age 18 and older. 3\. Willingness and ability to give written consent. 4\. Smoking greater than 10 cigarettes per day for at least 1 year. 5\. At least one prior attempt to stop smoking.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: 1\. pregnant or nursing women or women attempting to conceive; 2\. unstable cardiac disease; 3\. history of dermatoses.

How the Study Was Run

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

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

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

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

It started in 2005-01 with completion listed for 2009-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight Gain at 26 Weeks (time frame: 26 weeks). Point Prevalence Smoking Abstinence at 26 Weeks (time frame: 26 weeks).

It also tracked 3 secondary outcomes, for example Weight Gain at 6 Weeks, Point Prevalence Smoking Abstinence at 6 Weeks and Cigarettes Smoked Per Day.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 172 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.