Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes.

The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.

It had two arms (groups): BA + VLNC (experimental) and VLNC Only (active comparator).

Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.

The registry classes the interventions as behavioral and drug.

More on the Plan

Smokers who are interested in quitting will be randomly assigned to one of two treatment conditions.

They will also participate in weekly behavioral activation (BA) treatment sessions.

Following the quit date, both groups will receive standard nicotine replacement therapy.

At baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured using fMRI after 24 hr abstinence.

Who Took Part

Enrollment: 35 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Intact intellectual functioning (K-BIT2 \>79). Smoking at least 5 cigarettes per day. Expired CO concentration of at least 8 ppm or urinary cotinine \> 100 ng/mL. Interested in quitting smoking.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: inability to attend all experimental sessions; use of psychoactive medications or current participation in psychotherapy; current unstable psychiatric illness as assessed by clinical diagnostic interview.

How the Study Was Run

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

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-02-01 with completion listed for 2021-05-28.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward (time frame: baseline, week 5). Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward (time frame: baseline, week 5). Number of Participants Who Relapsed or Are Presumed to Have Relapsed (time frame: weeks 6 to 13).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 35 people.

Its size is small, so on its own it can only give an early look.

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.