Combination Nicotine Patch / Lorcaserin for Smoking Cessation

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Lorcaserin + Patch (experimental) and Patch (experimental).

The registry classes the interventions as drug.

Who Took Part

97 actual participants took part.

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

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

Examples of who could join: 18-65 years old;. Smoke an average of at least 10 cigarettes per day;. Have smoked at least one cumulative year;. Have an expired air CO reading of at least 10ppm;. Body weight of \>50 kg (110 lbs.).

The full record lists 7 inclusion and 42 exclusion criteria; among the exclusions: hypotension with symptoms (systolic \<90 mm hg, diastolic \<60 mm hg); coronary heart disease, diagnosed by coronary angiogram;; lifetime history of heart attack;.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

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 care provider.

It started in 2016-11-08 with completion listed for 2018-03-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time-to-lapse (time frame: Week 2 pre quit day). Smoking Withdrawal (time frame: Week 2 pre quit day).

It also tracked 6 secondary outcomes, for example Number of Participants Reporting Smoking Abstinence, Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment, Weight Gain Following Continuous Four-week Abstinence From Smoking, Number of Participants Reporting 6-month Smoking Abstinence, Percentage of Change in Ad Libitum Smoking at End of Week 2 and Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 97 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.