Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

Plain-language guide to NCT01857531: phase 2 interventional trial of Therapeutic nicotine (patch, non-peptide), 36 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01857531
Phase: phase 2
Status: completed
Start: 2013-06
Completion (planned or actual): 2013-07
Participants: 36 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Smoking Cessation
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking.

Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines.

This drug is considered investigational in the US.

It had 1 arm (groups): Ganaxolone -- Nicotine Patch (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 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: Have no known serious medical conditions;. Are 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;.

The full record lists 17 inclusion and 44 exclusion criteria; among the exclusions: inability to attend all required experimental sessions;; inability to take oral drugs or adhere to medication regimens;; hypertension (systolic \>140 mm hg, diastolic \>90 mm hg);.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

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

It started in 2013-06 with completion listed for 2013-07.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2 (time frame: Baseline and 2 Weeks).

It also tracked 1 secondary outcome, for example Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Therapeutic nicotine (patch, non-peptide) in 36 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.