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Behavioural Intervention

E-cigarette for Smoking

N/A

Recruiting

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (age ≥21)

Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 1 month follow-up

Awards & highlights

Study Summary

This trial aims to determine whether using e-cigarettes can help people with opioid use disorder reduce their cigarette smoking.

Who is the study for?

This trial is for smokers with opioid use disorder (OUD) who are currently in buprenorphine clinics. It's designed to see if e-cigarettes can help reduce harm from smoking. Participants should be actively seeking treatment and willing to try e-cigarettes as an alternative.Check my eligibility

What is being tested?

The study is testing the use of e-cigarettes as a less harmful substitute for regular cigarettes among OUD patients receiving buprenorphine treatment. The goal is to assess how feasible and acceptable this switch is within the clinic setting.See study design

What are the potential side effects?

E-cigarette use may lead to side effects such as throat irritation, coughing, dry mouth, dizziness, headaches or nausea. Long-term health impacts are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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I am currently on medication for opioid addiction.

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I plan to stay on buprenorphine for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 1 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 1 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 1 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of consented participants

Percentage of daily diary completed

Percentage of participants who report using the e-cigarette at least once a day

+2 more

Secondary outcome measures

Cigarette demand measured via the cigarette purchase task

Cigarette dependence measured via the Fagerstrom test for nicotine dependence

Combustible cigarette smoking

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: E-cigaretteExperimental Treatment1 Intervention

Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clemson UniversityOTHER

33 Previous Clinical Trials

5,863 Total Patients Enrolled

Prisma Health-UpstateLead Sponsor

82 Previous Clinical Trials

42,908 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment process ongoing for this medical study?

"As per clinicaltrials.gov, this study is actively pursuing participants. The trial was first listed on 6/20/2023 and most recently revised on 2/21/2024."

Answered by AI

What is the primary objective of conducting this medical study?

"During the first 4 weeks of this trial, the primary endpoint is to determine the percentage of participants who provide consent. Secondary measures include assessing cigarette dependence using the Fagerstrom test for nicotine addiction by comparing baseline and week 4 data, tracking combustible cigarette consumption changes from baseline to week 4, and analyzing smoking reduction by identifying participants who decrease their smoking habit by at least half."

Answered by AI

What is the number of individuals currently undergoing treatment within this medical study?

"Indeed, as per the details available on clinicaltrials.gov, this research investigation is actively seeking candidates. The trial was first made public on June 20th, 2023 and its most recent update occurred on February 21st, 2024. This study aims to enroll a total of 30 volunteers from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

E-cigarettes as a Harm Reduction Strategy

2023. "E-cigarettes as a Harm Reduction Strategy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06277271.