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Behavioural Intervention
Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation
N/A
Recruiting
Led By Jonathan Foulds, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Smoke >5 cigarettes per day for at least the prior 12 months
No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days (includes any nicotine replacement, varenicline, bupropion [used specifically as a quitting aid])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20
Awards & highlights
Study Summary
This trial will test if cigarettes with very low nicotine levels, along with e-cigs, help smokers with mental health conditions quit smoking.
Who is the study for?
This trial is for smokers who have smoked more than 5 cigarettes a day over the last year, with mental health conditions like mood, anxiety, psychotic or eating disorders. They shouldn't be planning to quit soon or have tried quitting in the past month. Participants need internet access and must not have serious physical illnesses or drug abuse issues.Check my eligibility
What is being tested?
The study tests the effects of very low nicotine cigarettes combined with either high-nicotine e-cigarettes or zero-nicotine e-cigarettes on people's health. It aims to understand if this combination can help individuals with mental health conditions manage their tobacco use.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to smoking cessation such as nicotine withdrawal symptoms (e.g., cravings, irritability), and those associated with e-cigarette use like throat irritation or coughing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been smoking more than 5 cigarettes daily for the last year.
Select...
I haven't tried to quit smoking seriously or used any quitting aids in the last 30 days.
Select...
I understand the study and agree to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)
Secondary outcome measures
Cigarette abstinence
Exhaled Carbon Monoxide
Kessler-6 score
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: VLNC cigarettes + Zero Nicotine Containing E-cigaretteExperimental Treatment2 Interventions
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid
Group II: VLNC cigarettes + High Nicotine Containing E-cigaretteExperimental Treatment2 Interventions
Participants are provided with very low nicotine content (VLNC) cigarettes (0.2 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Group III: NNC cigarettes + Zero Nicotine Containing E-cigaretteExperimental Treatment2 Interventions
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with zero nicotine e-liquid.
Group IV: NNC cigarettes + High Nicotine Containing E-cigaretteExperimental Treatment2 Interventions
Participants are provided with normal nicotine content (NNC) cigarettes (11.6 mg nicotine/cigarette) plus e-cigarette with high nicotine e-liquid.
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,490 Total Patients Enrolled
1 Trials studying Tobacco Addiction
450 Patients Enrolled for Tobacco Addiction
Milton S. Hershey Medical CenterLead Sponsor
495 Previous Clinical Trials
2,798,634 Total Patients Enrolled
Jonathan Foulds, PhDPrincipal Investigator - Penn State College of Medicine
Milton S. Hershey Medical Center
4 Previous Clinical Trials
683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant, nursing, or trying to become pregnant.I haven't had a serious heart condition, stroke, or uncontrolled high blood pressure in the last 3 months.I have been smoking more than 5 cigarettes daily for the last year.I have not had surgery under general anesthesia in the last 6 weeks.I haven't tried to quit smoking seriously or used any quitting aids in the last 30 days.I have not used any nicotine products other than cigarettes in the last week.I do not have severe respiratory, kidney, liver diseases, or uncontrolled immune disorders.I understand the study and agree to participate.I have been diagnosed with a mood, anxiety, psychotic, or eating disorder.You smoke regular or filtered cigarettes, or cigarettes made by a machine that has a filter.You must choose either regular or menthol cigarettes and stick to that choice throughout the trial.You have used an electronic cigarette for at least 5 days in the past month or within the past week before the screening.You do not plan to stop smoking for at least 3 weeks.You have been using marijuana or other illegal drugs, or using prescription drugs for non-medical purposes, on a daily or weekly basis in the past 3 months.You have allergies to propylene glycol or vegetable glycerin.You have smoked SPECTRUM research cigarettes within the last 6 months.I have had a seizure or been diagnosed with a seizure disorder in the last year.I am taking or have taken seizure prevention medications like Carbamazepine.I am willing to switch cigarettes and try an e-cig.You have a mental illness or substance abuse problem that is not under control or have been hospitalized for these issues in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: NNC cigarettes + Zero Nicotine Containing E-cigarette
- Group 2: NNC cigarettes + High Nicotine Containing E-cigarette
- Group 3: VLNC cigarettes + High Nicotine Containing E-cigarette
- Group 4: VLNC cigarettes + Zero Nicotine Containing E-cigarette
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Addiction Patient Testimony for trial: Trial Name: NCT04058717 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the study recruiting participants?
"Affirmative, according to the clinicaltrials.gov database this research is still on-going and actively recruiting individuals for participation. The project was initially listed on June 1st 2021 with a most recent update taking place July 14th 2022. 240 participants are needed at one designated location."
Answered by AI
Is this study open to new participants at the moment?
"Affirmative, clinicaltrials.gov confirms that this clinical trial is proactively searching for participants and has been doing so since the June 1st 2021 launch date. Approximately 240 patients have to be enrolled from one medical location before data collection can commence."
Answered by AI
Does the trial require participants to exceed a certain age threshold?
"This clinical trial is targeting participants aged 21-70, although there are separate studies for individuals under 18 and those over 65."
Answered by AI
Am I eligible to be a part of this clinical trial?
"This clinical study is open to a total of 240 individuals aged 21 and 70, who suffer from nicotine dependence. Prospective participants must satisfy the following criteria: be amenable towards using an e-cigarette or different strength cigarettes; have not attempted cigarette cessation in the last month nor plan on quitting within 3 weeks; possess no intentions for relocating away or taking extended vacations during trial period; meet lifetime diagnostic requirements for mood/anxiety/psychotic disorder as determined by MINI International Neuropsychiatric Interview Standard (version 7.0.2); smoke more than 5 daily filtered cigarettes with filter over 12 months prior."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have tried for years to quit smoking but cant because of the medications offered are not good for someone who is severely bipolar like I am.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Will I be able to do most of the trial virtually?
PatientReceived 2+ prior treatments
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