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Very low nicotine content cigarettes for Tobacco Use Disorder

Phase 1 & 2
Waitlist Available
Led By Sarah H. Heil
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-44 years
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will study the effects of exposure to cigarettes with varying levels of nicotine in pregnant smokers.

Who is the study for?
This trial is for pregnant women aged 18-44, who smoke and are less than 25 weeks into their pregnancy. They must have an education level of less than an Associate's degree. Men, those over 44 or under 18, or women more than 25 weeks pregnant cannot join.Check my eligibility
What is being tested?
The study compares the effects of smoking usual brand cigarettes versus very low nicotine content cigarettes (0.4 mg nicotine/g tobacco) in pregnant smokers over a period of 12 weeks after initial assessments.See study design
What are the potential side effects?
While specific side effects are not listed here, smoking cigarettes can lead to health issues such as increased heart rate, respiratory problems, and potential risks to the baby during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 44 years old.
Select...
I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cigarettes per day

Side effects data

From 2019 Phase 1 & 2 trial • 775 Patients • NCT02232737
35%
Infections and infestations
31%
Respiratory, thoracic, and mediastinal disorders
25%
Gastrointestinal disorders
23%
General disorders
19%
Nervous system disorders
17%
Musculoskeletal and connective tissue disorders
9%
Surgical and medical procedures
9%
Injury, poisoning, and procedural complications
8%
Vascular disorders
1%
Kidney infection
1%
Sudden onset of chest pain due to not enough blood going to the heart
1%
Anxiety, feelings of dread or danger
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.8 mg Nicotine
0.03 mg Nicotine
0.12 mg Nicotine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Very low nicotine content cigarettesExperimental Treatment1 Intervention
Group II: Usual BrandActive Control1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,625 Total Patients Enrolled
14 Trials studying Tobacco Use Disorder
5,684 Patients Enrolled for Tobacco Use Disorder
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,540 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
1,934 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,567 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
49,001 Patients Enrolled for Tobacco Use Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this medical trial?

"This investigation is inviting 111 individuals with nicotine addiction aged 18 to 44. Notably, applicants should be women in their first trimester of pregnancy (≤25 weeks)."

Answered by AI

Is the patient recruitment scope of this clinical trial limited to those aged 35 or older?

"This trial seeks participants of legal age, which is 18 years and above, but not exceeding 44 years."

Answered by AI

Is enrollment currently available for this trial?

"Per clinicaltrials.gov, this medical experiment is actively seeking participants. It was first listed on August 21st 2019 and the latest modification occurred on March 31st 2022."

Answered by AI

What is the current number of participants in this research project?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical study, which was initially posted on August 21st 2019, is currently recruiting patients to participate. 111 participants are needed from 3 separate treatment centres."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
John Hopkins University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Sarah Heil 2019. "Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04033237.
All > Vermont
~2 spots leftby Jul 2024
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