Smoking Tobacco and Drinking Study

What Was Tested

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

Both groups will be offered a nicotine patch starter kit.

The primary outcome is verified 7-day point prevalence abstinence from smoking at 3, 6, and 12 months.

It had two arms (groups): Tobacco Status Project (TSP) + Alcohol Intervention (experimental) and Tobacco Status Project Intervention (experimental).

Tobacco and alcohol intervention on Facebook and 14-day nicotine patch.

Tobacco intervention on Facebook and 14-day nicotine patch.

The registry classes the interventions as behavioral and drug.

More on the Plan

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use.

Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, 6, and 12 months follow-up.

Assessments will include measures on smoking and drinking patterns and thoughts about abstinence.

Who Took Part

179 actual participants took part.

It was open to people of any sex aged from 18 years up to 25 years.

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

Examples of who could join: Between 18 and 25 years of age. Indicate they use Facebook "most" (≥ 4) days per week. Have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week. Have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: do not read english; are not between 18 and 25 years of age; indicate they do not use facebook "most" (≥ 4) days per week.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2017-12-18 with completion listed for 2019-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months (time frame: 3 months post baseline). Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months (time frame: 6 months post baseline). Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months (time frame: 12 months post baseline).

It also tracked 11 secondary outcomes, for example Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment, Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time, Average Score on the Thoughts About Abstinence Questionnaire (Smoking), Average Number of Days of Heavy Episodic Drinking (HED) Over Time, Median Number of Drinks Per Week Over Time and Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 179 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.