Reward Sensitivity and Pharmacotherapy for Smoking Cessation

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.

It had two arms (groups): Varenicline + Placebo Patch (experimental) and Nicotine Patch + Placebo Tablet (experimental).

The registry classes the interventions as behavioral, drug and other.

More on the Plan

Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 2 study groups.

This is done because no one knows if one study group is better, the same, or worse than the other group.

You will have an equal chance of being assigned to Group 1 or 2. * If you are in Group 1, you will receive varenicline and a placebo patch.

A placebo is not a drug.

Who Took Part

204 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Interested in treatment that might change smoking behavior. Able to follow verbal and written instructions in English and complete all aspects of the study. Provide informed consent and agree to all assessments and study procedures. Have an address and telephone number where they may be reached. Be the only participant in their household.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: current enrollment or plans to enroll in another smoking cessation program in the next 12 months; plan to use other nicotine substitutes (i.e., otc or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months; uncontrolled hypertension (sbp greater than 180 or dbp greater than 110).

How the Study Was Run

It was run as a randomized, parallel-group and double-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.

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 2015-12-14 with completion listed for 2028-02-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Continuous Nicotine Abstinence (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Continuous and Prolonged Nicotine Abstinence.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 204 people.

Its status is active not recruiting; 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.