NCT00830739

A Multi-Modal Investigation of the Smoking Cessation Medication Varenicline: Dopaminergic Modulation of Reward Processing and Cognitive Control

Completed Last updated 5 July 2018

What this trial tests

trial in Tobacco Use Disorder in 61 participants. Completed in 26 February 2013.

Timeline

25 November 2008

26 February 2013

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	61
Start date	25 November 2008
Estimated completion	26 February 2013
Sites	1 location across United States

Conditions studied

• Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 55, any sex, with Tobacco Use Disorder or Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Chronic nicotine exposure through cigarette smoking affects the level of the brain chemical dopamine. Smokers who attempt to quit experience lower levels of dopamine, which increases anxiety and triggers nicotine cravings that make quitting more difficult.
* Varenicline (Chantix) is a smoking cessation medication that is designed to reduce nicotine craving and withdrawal by slightly increasing levels of dopamine in the brain. Research has shown that varenicline is a safe, well-tolerated, and effective treatment for nicotine dependence, but researchers are interested in learning more about how it affects the brain and its function. Functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will help researchers study the brain s response to nicotine and varenicline.

Objectives:

\- To explore how varenicline affects brain function and behavioral performance in current smokers and healthy volunteers.

Eligibility:

\- Individuals between 18 and 55 years of age who are either current smokers (10 or more cigarettes per day) or healthy nonsmoking volunteers.

Design:

* The study will involve nine testing and research visits over 5 to 6 weeks. The first visit will provide an initial assessment and training on the tasks that will be completed during the study.
* Six testing visits will involve fMRI and EEG measurements of brain activity. Each visit will contain two 2-hour scanning sessions, and each session will involve thinking tests. During these visits, participants will receive varenicline and placebo tablets, and wear nicotine patches and placebo patches that do not contain nicotine. Participants will not be told which tablet or patch they are given. This is a crossover study so all participants eventually get nicotine and placebo, as well as varenicline and placebo.
* Two other visits involve different thinking tasks. These visits will not require fMRI or EEG scans.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Down-regulation of amygdala and insula functional circuits by varenicline and nicotine in abstinent cigarette smokers.
   Sutherland MT, Carroll AJ, Salmeron BJ, Ross TJ, et al · · 2013 · cited 110× · PMID 23506999 · DOI 10.1016/j.biopsych.2013.01.035
2. Neural Signatures of Cognitive Flexibility and Reward Sensitivity Following Nicotinic Receptor Stimulation in Dependent Smokers: A Randomized Trial.
   Lesage E, Aronson SE, Sutherland MT, Ross TJ, et al · · 2017 · cited 36× · PMID 28403383 · DOI 10.1001/jamapsychiatry.2017.0400
3. Habenular and striatal activity during performance feedback are differentially linked with state-like and trait-like aspects of tobacco use disorder.
   Flannery JS, Riedel MC, Poudel R, Laird AR, et al · · 2019 · cited 17× · PMID 31633021 · DOI 10.1126/sciadv.aax2084