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Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Primary Purpose

Smoking Cessation, Tobacco Use, Tobacco Dependence

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contingency management

About this trial

This is an interventional basic science trial for Smoking Cessation focused on measuring tobacco, smoking, Tobacco Use, Tobacco Dependence, Smoking, Tobacco, Cigarette Smoking, Cigarette, Nicotine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

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.
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.
Legally mandated to complete a substance abuse treatment program.
Express a desire or intent to obtain additional substance abuse treatment while in the study.
Have history of psychotic symptoms such as hallucinations and delusions.
Have history of using other smoking cessation treatment, either psychotherapeutic or pharmacologic, in the past 2 months.
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.
The use of any prescription or over the counter medication that may affect the retinal dopamine system, including bromocriptine, antipsychotics, or anticholinergics.
If female, be currently pregnant, breastfeeding, or lack of effective birth control during 15 days prior to before the ERG.
The use of stimulant medications in the past 12 months.
Have a known hypersensitivity to stimulant medications
Have history of medical condition that contraindicates the use of methylphenidate, including any history of significant cardiovascular disease or abnormal screening EKG.
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.

Sites / Locations

NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contingency management

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03213418

First Posted

July 6, 2017

Last Updated

January 3, 2023

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT03213418

Brief Title

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Official Title

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

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.

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contingency management

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Contingency management

Intervention Description

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

Primary Outcome Measure Information:

Title

Abstinence

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Be between the ages of 18 to 55 years of age. Have an estimated average daily consumption of greater than 10 cigarettes. Have a Fagerstrom Nicotine Dependence Scale (FTND) >= 5. Is willing to try a method of smoking cessation without using any pharmacologic help for 3 months. Exclusion Criteria 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. 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. Legally mandated to complete a substance abuse treatment program. Express a desire or intent to obtain additional substance abuse treatment while in the study. Have history of psychotic symptoms such as hallucinations and delusions. Have history of using other smoking cessation treatment, either psychotherapeutic or pharmacologic, in the past 2 months. 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. The use of any prescription or over the counter medication that may affect the retinal dopamine system, including bromocriptine, antipsychotics, or anticholinergics. If female, be currently pregnant, breastfeeding, or lack of effective birth control during 15 days prior to before the ERG. The use of stimulant medications in the past 12 months. Have a known hypersensitivity to stimulant medications Have history of medical condition that contraindicates the use of methylphenidate, including any history of significant cardiovascular disease or abnormal screening EKG. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Luo, MD, PhD

Organizational Affiliation

New York State Psychiatric Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We will determine feasibility of IPD depending on resource allocation.

Learn more about this trial

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

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