Nicotine Replacement Therapy in Nicotine-dependent Arrestees

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

However, they have no access to tobacco during detention in police cells.

Nicotine withdrawal symptoms, that include irritability, anxiety and lack of concentration, may worsen the arrestee's health status during detention.

It had two arms (groups): nicotine replacement patch (experimental) and placebo patch (placebo comparator).

Single administration of a placebo patch.

The registry classes the interventions as drug and other.

More on the Plan

Nicotine withdrawal symptoms, including irritability, anxiety and lack of concentration, may worsen the arrestee's health status during detention.

Available medical guidelines in police custody do not mention nicotine dependence.

Evaluations will include the results of a medical examination during detention, a self-assessment by the arrestees of their desire to smoke, and medical consultations and evaluations of tobacco use 7-10 days, one month and six months later.

Primary endpoint: self-assessment of detention course by the arrestee (Likert scale).

Who Took Part

800 actual participants took part.

It was open to people of any sex aged from 18 years up to 76 years.

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

Examples of who could join: Arrestees examined by a physician during detention in police cells. Aged 18 or older. Smoking at least 10 cigarettes per day. Giving written consent to participate in the study. Health status compatible with detention in police cells.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: lack of understanding of the study; contra-indication to nicotine replacement therapy; health status incompatible with detention in police cells.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2017-01-03 with completion listed for 2020-11-25.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Perceived quality of detention in police cells at 8 hours following treatment administration (time frame: 8 hours maximum after treatment).

It also tracked 4 secondary outcomes, for example Rating of desire to smoke after treatment administration, Rating of intention to quit smoking after treatment administration;, Mean number of cigarettes per day at one month and Mean number of cigarettes per day at six months.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 800 people.

With 800 participants it is a large trial for this field.

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.