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NCT03213418 · ClinicalTrials.gov registry record · NA

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

A NA study, sponsored by New York State Psychiatric Institute.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT03213418: Clinical Trial NA study, sponsored by New York State Psychiatric Institute.

NCT03213418 is a NA study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03213418, a NA study, was terminated before completion, sponsored by New York State Psychiatric Institute.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Contingency management

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-02-01
Est. Completion 2022-12-01
Phase NA

Why NCT03213418 stopped before completion

NCT03213418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Contingency management is the first listed.

NCT03213418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03213418 about?

NCT03213418 is a clinical study titled "Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment". 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 t...

What is the current status of trial NCT03213418?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2018-02-01. Estimated completion is 2022-12-01.

What interventions are being tested in trial NCT03213418?

The interventions under investigation include: Contingency management (BEHAVIORAL).

Who is sponsoring clinical trial NCT03213418?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03213418's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03213418, the US trial registry maintained by the National Library of Medicine. NCT03213418 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.