Nicotine Withdrawal Symptoms and Smoking Relapse

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Background: \- Smoking is thought to cause changes in the brain that lead to addiction and craving.

Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating.

These symptoms make it difficult for people to stop smoking.

It had five arms (groups): active tDCS (active comparator), sham tDCS (sham comparator), Main Study - Treatment (other), Main Study - Non-Treatment (other) and Main Study - Motivational Interviewing (other).

(1) anodal left-dlPFC + cathodal right-vmPFC stimulation, with anode over the left dlPFC and cathode over the right-vmPFC; (2) cathodal left-dlPFC + anodal right-vmPFC stimulation, in which polarity is reversed between the two electrodes.

The registry classes the interventions as behavioral, device and drug.

More on the Plan

Objective The primary objective of the current protocol is to gain a greater understanding of the neurobiological mechanisms underlying acute nicotine withdrawal and contributing to the maintenance of, or return to smoking behavior among nicotine-dependent individuals, in the service of developing future smoking cessation treatments.

Study Population the researchers will recruit treatment seeking and non-treatment seeking smokers, as well as matched non-smoker control participants.

Main Study: To understand (1) the acute neurobiological effects of nicotine withdrawal on treatment-seeking and non-treatment seeking smokers, (2) the long term neurobiological outcomes of varenicline treatment and smoking cessation counseling at 1, 6, and 12 months.

The researchers will recruit 85 treatment seeking and 35 non-treatment seeking smokers for a within (nicotine deprivation), between (treatment-seeking status) subjects randomized, double blind, placebo controlled study.

Who Took Part

The registry lists 112 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Be between the ages of 18-65. Be right-handed. Assessment tool(s): Edinburgh Handedness Inventory. Smokers must meet the additional criteria:. In addition, non-smokers must meet:.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: the following exclusion criteria are new for the tdcs study:.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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.

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 and investigator.

It started in 2013-05-20 with completion listed for 2020-03-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation. dACC Glutamate (time frame: 12 hours nicotine abstinent (plus 1-2 hours after patch)). Behavioral Accuracy on N-Back Working Memory Task (time frame: During tDCS or sham stimulation. Day 1 for non-smokers. Day 1 or 2 for smokers (counterbalanced for nicotine condition)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 112 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.