Smoking Cessation for Depression and Anxiety Treatment

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

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

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

Both treatments also utilize nicotine replacement therapy.

It had two arms (groups): Depression and Anxiety Smoking Cessation Treatment (experimental) and Educational-Support Psychotherapy (active comparator).

Educational-based psychotherapy and standard smoking cessation treatment program.

The registry classes the interventions as behavioral and drug.

Who Took Part

12 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 7 inclusion and 8 exclusion criteria; among the exclusions: use of other tobacco products; currently suicidal or high suicide risk; concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression.

How the Study Was Run

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

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.

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 2014-10 with completion listed for 2016-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Smoking Status using the Timeline Follow-Back Assessment (time frame: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 12 people.

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

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.