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Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation in Opioid Use Disorder

Phase 2
Waitlist Available
Led By Stacey C. Sigmon, Ph.D.
Research Sponsored by University of Vermont
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 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether reducing the nicotine content in cigarettes and making e-cigarettes more appealing will help smokers with opioid use disorder quit smoking.

Who is the study for?
This trial is for daily smokers aged 21 to 70 who are currently being treated with methadone or buprenorphine for opioid use disorder. Participants must be stable on their opioid medication to join.
What is being tested?
The study tests the impact of low nicotine cigarettes and e-cigarettes on smoking behavior in people with opioid use disorder. It compares normal vs reduced nicotine cigarettes, and tobacco-flavored vs multiple flavor e-cigarettes over a period of 16 weeks.
What are the potential side effects?
While specific side effects aren't listed, typical ones from using reduced nicotine content cigarettes may include cravings and withdrawal symptoms. E-cigarette use can lead to throat irritation, coughing, or shortness of breath.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Cigarettes Smoked Per Day

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: RC 2 onlyExperimental Treatment1 Intervention
Research Cigarettes #2
Group II: RC 2 + EC 2Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #2
Group III: RC 2 + EC 1Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #1
Group IV: RC 1 onlyExperimental Treatment1 Intervention
Research Cigarettes #1

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
278 Previous Clinical Trials
3,743,834 Total Patients Enrolled
15 Trials studying Tobacco Use Disorder
5,490 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,426 Total Patients Enrolled
281 Trials studying Tobacco Use Disorder
49,398 Patients Enrolled for Tobacco Use Disorder
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,472 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
1,745 Patients Enrolled for Tobacco Use Disorder
Johns Hopkins UniversityOTHER
2,332 Previous Clinical Trials
14,874,590 Total Patients Enrolled
18 Trials studying Tobacco Use Disorder
3,903 Patients Enrolled for Tobacco Use Disorder
Stacey C. Sigmon, Ph.D.Principal Investigator - University of Vermont
University of Vermont
2 Previous Clinical Trials
275 Total Patients Enrolled

Media Library

Low Nicotine Content Cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04092101 — Phase 2
Tobacco Use Disorder Research Study Groups: RC 2 + EC 1, RC 2 + EC 2, RC 1 only, RC 2 only
Tobacco Use Disorder Clinical Trial 2023: Low Nicotine Content Cigarettes Highlights & Side Effects. Trial Name: NCT04092101 — Phase 2
Low Nicotine Content Cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092101 — Phase 2
~50 spots leftby Dec 2025
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