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Nicotine Replacement Therapy

Nicotrol with Behavioral Counseling for Tobacco Use Disorder

N/A
Waitlist Available
Led By Cheryl Oncken, MD MPH
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.

Eligible Conditions
  • Tobacco Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 4 trial • 154 Patients • NCT01656733
19%
Neonatal Abstinence Syndrome
11%
Throat irritation
6%
Low Birth Weigh (<2500 grams)
4%
Maternal Hospitalizationfor Medical Condition
4%
Preterm delivery
3%
Infant Respiratory Distress
1%
Infant Low Blood Sugar
1%
Increased mucus in throat
1%
Nausea
1%
Infant Bradycardia
1%
Cough
1%
Bad taste
1%
Spontaneous Abortion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Inhaler
Nicotrol Inhaler

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nicotrol with Behavioral CounselingExperimental Treatment1 Intervention
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
138 Previous Clinical Trials
19,387 Total Patients Enrolled
UConn HealthOTHER
214 Previous Clinical Trials
60,621 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
1,373 Patients Enrolled for Tobacco Use Disorder
Cheryl Oncken, MD MPHPrincipal InvestigatorUConn Health
~1 spots leftby Dec 2025
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