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TerminatedNCT03213418Updated Jan 5, 2023

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

An interventional study of Contingency management in Smoking Cessation, Tobacco Use and Tobacco Dependence, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Basic science

Why this study was 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.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

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.

02

Conditions studied

  • Smoking Cessation
  • Tobacco Use
  • Tobacco Dependence
  • Tobacco Use Disorder
  • Tobacco Smoking
  • Cigarette Smoking
  • Nicotine Dependence
  • Nicotine Use Disorder
  • Smoking
  • Smoking, Cigarette

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Keywords

  • tobacco
  • smoking
  • Tobacco Use
  • Tobacco Dependence
  • Smoking, Tobacco
  • Cigarette Smoking
  • Cigarette
  • Nicotine
03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 11 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Be between the ages of 18 to 55 years of age.
  2. Have an estimated average daily consumption of greater than 10 cigarettes.
  3. Have a Fagerstrom Nicotine Dependence Scale (FTND) >= 5.
  4. Is willing to try a method of smoking cessation without using any pharmacologic help for 3 months.

Exclusion criteria

Exclusion Criteria

  1. Present with a serious psychiatric illness or substantial suicide or violence risk, as assessed by a licensed clinician involved in the screening phase of the study.
  2. Present with any history or current substance use disorder (other than tobacco use disorder), or significant substance use for any substance other than nicotine, alcohol or caffeine, defined as greater than once weekly use.
  3. Legally mandated to complete a substance abuse treatment program.
  4. Express a desire or intent to obtain additional substance abuse treatment while in the study.
  5. Have history of psychotic symptoms such as hallucinations and delusions.
  6. Have history of using other smoking cessation treatment, either psychotherapeutic or pharmacologic, in the past 2 months.
  7. Have history of any chronic medical or ophthalmologic diseases that may affect retinal function (including but not limited to diabetes, age related macular degeneration, retinitis pigmentosa, narrow angle glaucoma, or neurological conditions, such as Parkinson's disease) and that may affect ERG recordings.
  8. The use of any prescription or over the counter medication that may affect the retinal dopamine system, including bromocriptine, antipsychotics, or anticholinergics.
  9. If female, be currently pregnant, breastfeeding, or lack of effective birth control during 15 days prior to before the ERG.
  10. The use of stimulant medications in the past 12 months.
  11. Have a known hypersensitivity to stimulant medications
  12. Have history of medical condition that contraindicates the use of methylphenidate, including any history of significant cardiovascular disease or abnormal screening EKG.
  13. Is unable to understand or consent to study procedure, or is in the opinion of the study clinician to be unlikely to be able to tolerate the study treatment procedure.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Contingency management

    Behavioral: Contingency management

Interventions

  • BehavioralContingency management

    Contingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives.

06

What researchers measure

Primary outcomes

  1. Abstinence

    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.

    Time frame: 1 month

07

Study locations

1 site
  • NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor
    New York, New York 10019, United States
08

References and documents

Individual participant data

Plan to share: Undecided — We will determine feasibility of IPD depending on resource allocation.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03213418
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sean Luo (Research Psychiatrist, New York State Psychiatric Institute) — Principal investigator
First posted
Jul 11, 2017
Start date
Feb 1, 2018
Primary completion
Nov 1, 2022
Completion
Dec 1, 2022
Last update
Jan 5, 2023

Study contacts

Sean Luo, MD, PhD
principal investigator · New York State Psychiatric Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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