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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
Sponsor:
Information provided by (Responsible Party):
Sean Luo, New York State Psychiatric Institute

Study Description
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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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Contingency management Behavioral: Contingency management
Contingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor
New York, New York, United States, 10019
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Sean Luo, MD, PhD New York State Psychiatric Institute
More Information
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Responsible Party: Sean Luo, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03213418    
Other Study ID Numbers: 7519
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will determine feasibility of IPD depending on resource allocation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Luo, New York State Psychiatric Institute:
tobacco
smoking
Tobacco Use
Tobacco Dependence
 Smoking, Tobacco
Cigarette Smoking
Cigarette
Nicotine
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Pathologic Processes
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders