Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

What Was Tested

This registered phase 1, phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms.

It had two arms (groups): Standard smoking cessation (active comparator) and BA for substance abusing smokers (experimental).

Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

The registry classes the interventions as behavioral and drug.

More on the Plan

This project will take place in two phases.

In the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing Smokers (BA-DAS).

In Phase II, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS (which includes ST and NRT).

Who Took Part

96 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: Between 18 and 65 years of age. Regular smoker for at least one year. Currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day. Report motivation to quit smoking in the next month. Report elevated depressive symptoms.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: physical concerns contraindicating the nicotine patch; limited mental competency and/or the inability to give informed, voluntary, written consent to participate; use of psychotropic medication for \< 3 months.

How the Study Was Run

Design: randomized, parallel-group and single-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.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2011-12 with completion listed for 2015-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date (time frame: 26 weeks post quit date).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 96 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.