Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

This study will investigate the underlying neurobiology of differences between male and female smokers.

It had four arms (groups): Women- denicotinized cigarette (experimental), Men- denicotinized cigarette (experimental), Women -nicotine patch (experimental) and Men- nicotine patch (experimental).

The registry classes the interventions as drug and other.

More on the Plan

In the proposed study, adult male and female (10 per group) treatment-seeking nicotine-dependent individuals will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under three conditions during a seven day period: baseline, after NRT, and after denicotinized cigarette facilitated-extinction.

Scanning procedures will be repeated on day 3.

Subjects will then receive denicotinized cigarettes for ad lib smoking on days three through seven.

Subjects will be asked to remain abstinent throughout the study period and they will be assessed daily with self-report, Carbon Monoxide (CO) monitor and for nicotine withdrawal.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

Examples of who could join: Age 21 - 60. Participants will have afternoon end-expired carbon monoxide levels of at least 15 p.p.m. to confirm smoke inhalation. Moderate to high levels of nicotine dependence confirmed by Fagerstrom Test of Nicotine Dependence score. General good health confirmed by history \& physical, serum chemistries, complete blood count, urinalysis, and electrocardiogram. Able to read and understand questionnaires and informed consent.

The full record lists 12 inclusion and 12 exclusion criteria; among the exclusions: currently meets diagnostic and statistical manual (dsm)-iv criteria for any other psychoactive substance dependence disorder except nicotine dependence; any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen; use of other tobacco products.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-03 with completion listed for 2012-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Post- Cue Exposure Craving Nicotine Patch (time frame: Day 3). Post- Cue Exposure Craving Denicotinized Cigarettes (time frame: Day 7).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 33 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.