Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment
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|ClinicalTrials.gov Identifier: NCT03213418|
Recruitment Status : Terminated (Due to delay in recruitment during COVID and cost considerations, the study will need to end without meeting its recruitment target and meeting compliance requirements.)
First Posted : July 11, 2017
Last Update Posted : January 5, 2023
This project aims to develop electroretinogram as a new putative marker for dopamine release, and as a predictor of treatment response among patients seeking treatment for smoking cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a neurotransmitter released in the brain. Several lines of evidence suggest that dopamine release deficit in the brain is involved in the development and maintenance of nicotine dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine release will more readily respond to behavioral treatment for smoking cessation, and in particular, financial incentives contingent on abstinence (Contingency Management). Previous pilot data suggest electroretinogram (ERG), which records electrical signals from the retina in response to light, is a clinically accessible correlate to dopamine release in the brain. The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of central dopamine release may have a large number of future applications in the diagnosis and treatment of other mental illnesses and substance use disorders.
The study will recruit normal controls and smokers, measure ERG before and after a standard dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized treatment course of CM. The investigators will test whether smoking status and the response to CM are correlated to changes in ERG in response to methylphenidate challenge.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Tobacco Use Tobacco Dependence Tobacco Use Disorder Tobacco Smoking Cigarette Smoking Nicotine Dependence Nicotine Use Disorder Smoking Smoking, Cigarette||Behavioral: Contingency management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment|
|Actual Study Start Date :||February 1, 2018|
|Actual Primary Completion Date :||November 1, 2022|
|Actual Study Completion Date :||December 1, 2022|
|Experimental: Contingency management||
Behavioral: Contingency management
Contingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives.
- Abstinence [ Time Frame: 1 month ]Prolonged abstinence from cigarette smoking will be measured through a combination of self-reported timeline follow back, as it is corroborated with urine cotinine and expired CO levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213418
|United States, New York|
|NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor|
|New York, New York, United States, 10019|
|Principal Investigator:||Sean Luo, MD, PhD||New York State Psychiatric Institute|