DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy
7. august 2026 opdateret af: Amanda Palmer, Medical University of South Carolina
High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes
This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use.
Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20/day), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30/day).
All groups receive evidence-based behavioral support through the EX Program.
Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks.
A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
321
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rachel Program Coordinator
- Telefonnummer: (843)737-1516
- E-mail: chrisrac@musc.edu
Undersøgelse Kontakt Backup
- Navn: Talia Program Assistant
- Telefonnummer: 843-259-8111
- E-mail: ogretmet@musc.edu
Studiesteder
-
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- age 18+;
- report nicotine-containing e-cigarette use 5+ times per day, >5 days per week, for > 6 months;
- smoking >1 cigarette per day, >5 days per week, for >6 months;
- interest in quitting cigarettes and e-cigarettes within the next month (>6 on 10-point scale);
- willing to try nicotine replacement therapy;
- access to text/internet/email.
Exclusion Criteria:
- report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) >1 time per week in the past 3 months;
- have medical contraindications for nicotine replacement therapy use (patch and lozenge; e.g., recent myocardial infarction, arrhythmias, angina, vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated such as PKU);
- report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies);
- endorse symptoms of Cannabis Use Disorder (using the CUDIT assessment);
- unable to consent (e.g., cognitive deficit, non-English speaking);
- live outside the US.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Behavioral Support
Participants will receive behavioral support only.
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Participants will enroll in the Ex Program for support in quitting smoking and vaping.
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Eksperimentel: Standard dose NRT
Participants will receive a standard dose of nicotine replacement therapy (NRT).
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Participants will enroll in the Ex Program for support in quitting smoking and vaping.
21mg patch
21mg + 14mg patch
4mg; 5-20/day
4mg; 5-30/day
|
|
Eksperimentel: High dose NRT
Participants will receive a higher dose of NRT than what is typically used.
|
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
21mg patch
21mg + 14mg patch
4mg; 5-20/day
4mg; 5-30/day
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dual use abstinence
Tidsramme: Week 12, Week 24
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7-day point prevalence biochemically-confirmed abstinence from both e-cigarettes and cigarettes.
E-cigarette abstinence is based on self-report and cotinine (if no longer using NRT) and cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation.
Non-responders and missing data will be coded as not abstinent.
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Week 12, Week 24
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Cigarette abstinence
Tidsramme: Weeks 12, Week 24
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7-day point prevalence biochemically-confirmed abstinence from cigarettes (and still using e-cigarettes).
Cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation.
Non-responders and missing data will be coded as not abstinent.
|
Weeks 12, Week 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. oktober 2026
Primær færdiggørelse (Anslået)
10. april 2030
Studieafslutning (Anslået)
10. juli 2031
Datoer for studieregistrering
Først indsendt
4. august 2026
Først indsendt, der opfyldte QC-kriterier
4. august 2026
Først opslået (Faktiske)
10. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00150067
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data will be uploaded to the National Institute of Mental Health (NIMH) Data Archive (NDA).
All participant data uploaded to the repository will be de-identified.
Shared data will include participants' self-reported survey responses, assessment scores, and results of biospecimen assays.
IPD-delingsadgangskriterier
The NDA controls data access.
Researchers need to request access, which is then decided upon by the NDA Data Access Committee.
Standard NDA data access permits one-year access that is renewable.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .