Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

What Was Tested

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

It had two arms (groups): patch+spray (experimental) and patch+placebo spray (placebo comparator).

Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.

Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.

The registry classes the interventions as drug.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ages 21 and over. Able to read and write in English.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines; women who are pregnant or nursing; suicidal, homicidal, or evidence of severe mental illness.

How the Study Was Run

It was run as a randomized, crossover 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.

Each person switched between Therapeutic nicotine (patch, non-peptide) and the comparison at some point, usually with a gap in between.

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 2006-01 with completion listed for 2016-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Drinks Consumed During an Ad-libitum Drinking Period (time frame: Two hour ad-libitum drinking period during laboratory session).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 22 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.