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NCT03213418

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Terminated NA Last updated 5 January 2023
What this trial tests

NA trial testing Contingency management in Smoking Cessation in 11 participants. Terminated before completion.

Timeline
1 February 2018
Primary endpoint
1 November 2022
1 December 2022

Quick facts

Lead sponsorNew York State Psychiatric Institute
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment11
Start date1 February 2018
Primary completion1 November 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

New York State Psychiatric Institute

Who can join

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Contingency management

Trials testing the same drug.

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

Other New York State Psychiatric Institute trials

Trials by the same sponsor.

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Data sources for this page

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