Smoking CessationNCT03213418
Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment
A study testing Contingency management in people with Smoking Cessation and Tobacco Use, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use, Tobacco Dependence
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYSPI, STARS Clinic, 3 Columbus Circle, suite 1408, 14th Floor
New York, New York, 10019
About this study
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
- Being tested
- Contingency management
- Keywords
- tobacco, smoking, Tobacco Use, Tobacco Dependence, Smoking, Tobacco, Cigarette Smoking, Cigarette, Nicotine
- Medical subject headings
- Smoking Cessation, Tobacco Use, Tobacco Use Disorder, Tobacco Smoking, Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Contingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives.
| Study group | Role | What they receive |
|---|---|---|
| Contingency management | Experimental | Not described Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Feb 2018
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Luo, New York State Psychiatric Institute
- Investigators
- Sean Luo, MD, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213418
- Sponsor's protocol ID
- 7519
- Status last verified
- Jan 2023
- First submitted
- 6 Jul 2017
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will determine feasibility of IPD depending on resource allocation.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT03213418
- Acronym / sponsor ID
- 7519
- Conditions
- Smoking Cessation, Tobacco Use, Tobacco Dependence, Tobacco Use Disorder, Tobacco Smoking, Cigarette Smoking
- Keywords
- tobacco, smoking, Tobacco Use, Tobacco Dependence, Smoking, Tobacco, Cigarette Smoking, Cigarette, Nicotine
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency management | Experimental | Behavioral: Contingency management |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementContingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives. | Behavioural | Contingency management |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided. We will determine feasibility of IPD depending on resource allocation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Luo, MD, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Smoking Cessation and Tobacco Use, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.