The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

No studies have assessed the effects of nicotine withdrawal on reward responsivity in patients with schizophrenia.

The registry classes the interventions as drug.

More on the Plan

A syndrome of negative affect and anhedonia has been described as an important component in maintenance of dependence on nicotine.

If the syndrome of anhedonia can be measured objectively and quantitatively, the researchers will be better able to test treatments for this withdrawal syndrome.

It is their hypothesis that the syndrome of anhedonia during early abstinence from nicotine is quantifiable as a deficit in reward responsivity.

Brain stimulation reward thresholds have been used to measure anhedonia and responsivity to reward in animal models.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age 18-55 inclusive. Able to provide informed consent. Self reported smoking of 20 or more cigarettes per day for at least 12 months. FTND score of \>/= 5. Expired air CO of \>/= 10 ppm.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: current unstable serious medical illness such as uncontrolled high blood pressure, untreated ischemic heart disease; use of any cholinesterase inhibitor such as galantamine in the past 3 months; history of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, tapes or nicotine patches.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

In the crossover set-up each of the participants took both Therapeutic nicotine (patch, non-peptide) and the comparison in turn, acting as their own control.

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

It started in 2005-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Reward Responsivity using a signal detection task.

It also tracked 2 secondary outcomes, for example Cognitive drug research cognitive battery and Source monitoring task to assess verbal memory.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 40 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.