Enhancing Smoking Cessation in the Homeless Population

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The goal of this research study is to enhance smoking cessation rates for homeless smokers.

The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation the researchers will utilize a 3-group randomized design to test study hypotheses.

The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC).

It had two arms (groups): Integrated Intensive Smoking + Alcohol (active comparator) and Usual Care (placebo comparator).

IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.

UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines.

The registry classes the interventions as behavioral and drug.

More on the Plan

To achieve the study goal, the researchers have selected a 3-group randomized clinical trial (RCT) design that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive Smoking and Alcohol Intervention.

The researchers understand that testing hypothesis 3 confounds contact time with treatment content, and hence the researchers will not be able to determine that observed differences in outcome are due to specific treatment components.

Subsequent research will be needed to disentangle various intervention components.

Counseling will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.

Who Took Part

The registry lists 352 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Smoked at least 100 cigarettes in lifetime. AUDIT score of \> or equal to 5, \< or equal to 26. Aged 18 years or older. Willing to attend study sessions and follow other study protocol.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: use of smoking cessation medications or interventions in last 30 days; unstable medical illness that requires immediate medical care; AUDIT score of \< 5 or \> 26.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-01 with completion listed for 2018-10-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): CO-verified Smoking Status at 26 Weeks (time frame: 7-day smoking abstinence at week 26 follow-up).

It also tracked 1 secondary outcome, for example CO-verified Smoking Status at 12 Weeks.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 352 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.