← Back to Search

Other

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Cigarettes Smoked Per Day

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor

266 Previous Clinical Trials

3,743,381 Total Patients Enrolled

14 Trials studying Tobacco Use Disorder

5,440 Patients Enrolled for Tobacco Use Disorder

National Institute on Drug Abuse (NIDA)NIH

2,463 Previous Clinical Trials

2,617,033 Total Patients Enrolled

271 Trials studying Tobacco Use Disorder

48,757 Patients Enrolled for Tobacco Use Disorder

Food and Drug Administration (FDA)FED

171 Previous Clinical Trials

1,331,296 Total Patients Enrolled

9 Trials studying Tobacco Use Disorder

1,690 Patients Enrolled for Tobacco Use Disorder

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

Frequently Asked Questions

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

What are the general requirements to participate in this clinical trial?

"The aim of this clinical trial is to study 310 individuals aged 21-70 who are struggling with tobacco dependence. In addition, these patients must meet the following age criteria:"

Answered by AI

Are recruitment efforts for this clinical trial still underway?

"The listed clinical trial on clinicaltrials.gov is currently recruiting patients. This particular study was originally posted on September 24th, 2019 and has had updates as recently as April 6th, 2021."

Answered by AI

Does this research require that participants be of a certain age?

"This clinical trial is only for patients between the ages of 21 and 70. Out of 275 trials, this is one of 895 that focuses on patients outside of the age bracket of 18-65."

Answered by AI

Could you please elucidate the risks of cigarette smoking with different nicotine levels?

"The Power team gave cigarettes with different nicotine content a score of 2. This is because, although there is some evidence that they are safe, there is no data supporting that they are effective."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

Stacey C. Sigmon 2019. "Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092101.