Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

What Was Tested

The trial (phase 3) is built around Therapeutic nicotine (patch, non-peptide).

To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation. 3.

To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.

It had three arms (groups): Placebo (sugar pill) (placebo comparator), Topiramate (active comparator) and Topiramate and Nicotine patch (active comparator).

Person receives an inactive placebo.

The registry classes the interventions as drug.

More on the Plan

This is a 10-week, randomized, double-blind, single-site study of treatment with either: topiramate, or placebo, or topiramate plus nicotine patch.

Approximately, 90 subjects ages 18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with the intention of 60 subjects being eligible for randomized treatment (20 per arm).

Who Took Part

The registry lists 57 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: BMI \> 18kg/in2. Subjects must be free of serious or unstable disease within the past 6 months. Subjects must be able to be seen as an outpatient, to be assessed in a clinic setting, and able and willing to comply with all study visits. Subjects must be able to provide written consent. Subjects must be the only member of the household participating in this study.

The full record lists 8 inclusion and 26 exclusion criteria; among the exclusions: subjects who are currently suffering from depression or have been diagnosed with depression or treated with an antidepressant within the past 12 months; subjects who have a past or present history of psychosis, panic disorder, or bipolar disorder; subjects who have an sgot (ast) or sgpt (alt) concentration greater than 1.5 times the upper limit of normal.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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, investigator and outcomes assessor.

It started in 2006-04 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment (time frame: weeks 7-10).

It also tracked 1 secondary outcome, for example MNWS.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 57 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.