Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The use of supplemental nicotine administration (SNA) during a "pre-treatment" phase before a targeted quit date is an innovative development in smoking cessation, and may be helpful in treating smokers with PTSD.

It had two arms (groups): Nicotine Patch (active comparator) and placebo patch (placebo comparator).

Nicotine patch given pre-quit attempt at weeks 4 through 6.

Placebo patch given pre-quit from weeks 4 through 6.

The registry classes the interventions as drug.

Who Took Part

The registry lists 69 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Between ages of 18 and 70. Smoker who has smoked 10 or more cigarettes per day during past year. Study physician clearance.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: organic mental disorder, schizophrenia, current manic syndrome, lifetime but not current ptsd, or current substance abuse/dependence; unstable medications; myocardial infarction in past 6 months.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2009-11 with completion listed for 2014-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Participants Self-reporting Abstinence During 6 Weeks Post Quit (time frame: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12).

It also tracked 1 secondary outcome, for example Abstinence as Measured by Exhaled Carbon Monoxide (CO).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 69 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.