Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

NCT03213418 | Terminated

• 1 other identifier: 7519
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  1 month

Study Arms (1)

Contingency management

EXPERIMENTAL

Behavioral: Contingency management

Interventions

Contingency management BEHAVIORAL

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

Contingency management

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

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

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use; Tobacco Use Disorder; Tobacco Smoking; Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sean Luo, MD, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: February 1, 2018
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

US (1)