Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

It had three arms (groups): Health Education (HE) Group (experimental), Culturally Tailored Smoking Cessation (CTSC) Group (experimental) and Culturally Tailored Smoking + Adherence Enhancement (AE) Group (experimental).

Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

The registry classes the interventions as behavioral, drug and other.

More on the Plan

These should take about 1½ hours to complete. * You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body.

If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance. * If you can become pregnant, you will have a urine pregnancy test.

To take part in this study, you must not be pregnant.3 * The total length of the baseline visit will be approximately 2.5 hours.

Study Groups: You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adults at least 18 years of age. Current smoker (\>5 cigarettes per day for the past 3 months). Able to speak and read English or Spanish. Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up. Willing to set a quit date within 2 weeks of enrollment date.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: individuals suffering from any unstable medical condition precluding the use of nrt (identified using the medical history questionnaire given at baseline); currently using smokeless tobacco, electronic nicotine delivery systems (ends), nicotine replacement therapy, or other smoking cessation treatment; pregnant or nursing.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2015-11-02 with completion listed for 2017-08-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Intervention Feasibility & Acceptability (time frame: Averaged across 3 study visits (Week 0 to Week 12)). Patch Adherence: Percentage of Days With Patch (time frame: This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment). Number of Abstinent Participants (time frame: Collected at the 3- and 6-month follow-up visits).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 26 people.

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

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.