Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Not Applicable

Terminated

• Conditions: Smoking Cessation; Tobacco Use; Tobacco Smoking; Nicotine Use Disorder; Cigarette Smoking; Nicotine Dependence; Smoking; Tobacco Dependence; Tobacco Use Disorder; Smoking, Cigarette
• Interventions: Behavioral: Contingency management

• Registration Number: NCT03213418
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2018-02-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contingency management	Contingency management	-

Primary Outcome Measures

Name	Time	Method
Abstinence	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.

Trial Locations

Locations (1)

NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor; 🇺🇸 New York, New York, United States