Nicotine Patch Trial in Syrian Primary Care Settings

What Was Tested

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

It had two arms (groups): Arm A (experimental) and Arm B (placebo comparator).

Behavioral Counseling and Nicotine Patch.

Behavioral counseling and placebo patch.

The registry classes the interventions as drug.

More on the Plan

Clinic physicians will be trained to provide a brief assessment of each patient's smoking status and motivation to quit, and to refer appropriate patients to a cessation clinic within the primary care center.

Eligible and interested smokers will be randomized to receive behavioral cessation counseling + nicotine patch or behavioral cessation counseling + placebo patch.

Behavioral counseling will be delivered by a physician at each clinic.

After eligibility is determined and a description of the cessation program has been provided, written informed consent will be obtained.

Who Took Part

The registry lists 269 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18-65 years of age. Smoking continuously for at least one year and smoking 5 cigarettes every day. Reside in the catchment area of one of the four primary care centers.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: diagnosed with a generalized dermatology disease, liver failure, hyperthyroidism, or pheochromocytoma; current use of psychotropic drugs; past year history of drug or alcohol abuse, unstable cardiovascular, psychiatric, or debilitating diseases based on physician assessment.

How the Study Was Run

It was run as a randomized, parallel-group and triple-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.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-08 with completion listed for 2009-07.

It ran at 1 site in Syria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Prolonged Abstinence (time frame: 7 weeks, 6 months and 12 months).

It also tracked 3 secondary outcomes, for example 7 day point prevalent abstinence, Withdrawal symptoms and Depressive symptomatology.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 269 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.