Smoking Termination / Anxiety Reduction Treatment (ST/ART)

What Was Tested

The trial (phase 1) is built around Therapeutic nicotine (patch, non-peptide).

The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders.

The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START).

Both treatments also utilize nicotine replacement therapy.

It had two arms (groups): one (active comparator) and Educational-Support Psychotherapy (active comparator).

Educational-based psychotherapy and standard smoking cessation treatment program.

The registry classes the interventions as behavioral and drug.

More on the Plan

The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders.

The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies.

During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol.

The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect.

Who Took Part

Enrollment: 74 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: Ages 18-65 years old. Capable of providing informed consent. Willing to attend all study visits and comply with the protocol. Daily smoker for at least one year. Currently smoke an average of at least 6 cigarettes per day.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: use of other tobacco products; currently suicidal or high suicide risk; unwilling to cease use of benzodiazepines or other fast-acting anxiolytics.

How the Study Was Run

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

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2012-03 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Short- and long-term point prevalence abstinence (time frame: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day).

It also tracked 1 secondary outcome, for example Time to first smoking lapse and relapse.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 74 people.

The trial is marked completed; 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.