Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia.

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (placebo comparator).

Placebo patch.

The registry classes the interventions as drug.

More on the Plan

Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking.

Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied.

After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues.

This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.

Who Took Part

Enrollment: 48 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Smokes between 20 and 50 cigarettes per day. Diagnosis of schizophrenia or schizoaffective disorder.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: if enrolled in the control group, must not be diagnosed with a psychiatric disorder; currently dependent on alcohol or any drug (other than nicotine); currently trying to quit smoking.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

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

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2002-06 with completion listed for 2005-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Smoking behavior (measured by automated topography) (time frame: after 5 hrs abstinence).

It also tracked 3 secondary outcomes, for example Adverse events (measured by self-report throughout the study), Nicotine withdrawal severity and Smoking urge.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 48 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.