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Sammenligning af to adfærdsmæssige tilgange til rygestop i mentale sundhedsindstillinger (MTQT)

4. november 2026 opdateret af: Wake Forest University Health Sciences

The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness.

In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial.

Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population.

In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482).

The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
343

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater, 14260-1660
        • University at Buffalo
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Health Sciences

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
  2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
  3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
  4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
  5. Age 18 and older;
  6. Willing and medically eligible to use NRT;
  7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).

Exclusion Criteria

  1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
  2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
  3. Being pregnant or the intention to become pregnant in the next 6 months;
  4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
  5. Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
  6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).

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

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: "Quit on the Go" (formerly "Learn to Quit")

A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Enhed: Quit on the Go App (formerly "Learn to Quit " App)

A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms.

Medicin: Nicotine patch

All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.

Andre navne:
  • NRT
Adfærdsmæssigt: Smartphone coaching

Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app.

Medicin: Nicotine gum

Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.

Andre navne:
  • NRT
Medicin: Nicotine Lozenges

In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.

Andre navne:
  • NRT
Andet: Brief Advice (Standard of Care)

Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).
Medicin: Nicotine patch

All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.

Andre navne:
  • NRT
Medicin: Nicotine gum

Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.

Andre navne:
  • NRT
Medicin: Nicotine Lozenges

In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.

Andre navne:
  • NRT
Adfærdsmæssigt: Brief advice

Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bio-verified 7-day point-prevalence abstinence at 24 weeks
Tidsramme: At 24 weeks from Baseline

Abstinence is binary, and requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. If the participant does not meet both criteria, they are not considered abstinent.

As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, or fail to provide a breath and saliva sample at the time-point.
At 24 weeks from Baseline

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in average number of cigarettes smoked per day
Tidsramme: At 24 weeks from Baseline

Change in self-reported number of cigarettes smoked per day, averaged within groups.
At 24 weeks from Baseline
Average number of 24-hr quit attempts per group
Tidsramme: At 24 weeks from Baseline

Average number of quit attempts self-reported per group between baseline and week 24. Quit attempts are defined by no smoking at all for 24 hours or more.
At 24 weeks from Baseline
7-day point prevalence abstinence rates
Tidsramme: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
At 12 weeks from Baseline
7-day point prevalence abstinence rates
Tidsramme: At 24 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
At 24 weeks from Baseline
30-day point prevalence abstinence rates
Tidsramme: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
At 12 weeks from Baseline
30-day point prevalence abstinence rates
Tidsramme: At 24 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
At 24 weeks from Baseline
Biochemically confirmed 7-day point prevalence abstinence rates
Tidsramme: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the time point. Abstinence requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. If the participant does not meet both criteria, they are not considered abstinent.
At 12 weeks from Baseline

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average frequency of app use
Tidsramme: Weeks 0-24

Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Weeks 0-24
Average duration of app use
Tidsramme: Weeks 0-24

Average duration of app use over the 24-week study period.
Weeks 0-24
Average number of app modules completed
Tidsramme: Weeks 0-24

Average number of app modules completed over the 24-week study period.
Weeks 0-24
Average app usability scores
Tidsramme: At 4 weeks from baseline

Average self-reported scores of usability on the 10-item System Usability Scale. Scores range from 0-100 with higher scores indicating higher usability of the app.
At 4 weeks from baseline
Average user experience scores
Tidsramme: At 4 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 4 weeks from baseline
Average user experience scores
Tidsramme: At 12 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 12 weeks from baseline
Average user experience scores
Tidsramme: At 24 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 24 weeks from baseline
Average acceptance of physical smoking cravings
Tidsramme: At 4 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 4 weeks from baseline
Average acceptance of physical smoking cravings
Tidsramme: At 12 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 12 weeks from baseline
Average acceptance of physical smoking cravings
Tidsramme: At 24 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 24 weeks from baseline
Nicotine patch use
Tidsramme: At 12 weeks from baseline

Average number of days (out of 56 possible) per arm that participants used the nicotine patch.
At 12 weeks from baseline
Nicotine gum use
Tidsramme: At 12 weeks from baseline

Average number of nicotine gum used per arm.
At 12 weeks from baseline
Smoking Costs at 4 Weeks
Tidsramme: At 4 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 4 weeks from baseline
Smoking Costs at 12 Weeks
Tidsramme: At 12 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 12 weeks from baseline
Smoking Costs at 24 Weeks
Tidsramme: At 24 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 24 weeks from baseline
Costs of technical coaching
Tidsramme: At 24 weeks from baseline

Cost of technical coaching calls estimated by number of technical coaching calls to assist with the use of the QoG DTx
At 24 weeks from baseline
Experiences of racism at week 4
Tidsramme: At 4 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 4 weeks from baseline
Experiences of racism at week 12
Tidsramme: At 12 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 12 weeks from baseline
Experiences of racism at week 24
Tidsramme: At 24 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 24 weeks from baseline
Quality of Life at week 4
Tidsramme: At 4 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 4 weeks from baseline
Quality of Life at week 12
Tidsramme: At 12 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 12 weeks from baseline
Quality of Life at week 24
Tidsramme: At 24 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 24 weeks from baseline
Frequency of e-cigarette use at Week 4
Tidsramme: At 4 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 4 weeks from baseline
Frequency of e-cigarette use at Week 12
Tidsramme: At 12 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 12 weeks from baseline
Frequency of e-cigarette use at Week 24
Tidsramme: At 24 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 24 weeks from baseline
Frequency of use of other tobacco products at week 4
Tidsramme: At 4 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of other tobacco products at week 12
Tidsramme: At 12 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of other tobacco products at week 24
Tidsramme: At 24 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline
Frequency of use of cannabis at week 4
Tidsramme: At 4 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of cannabis at week 12
Tidsramme: At 12 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of cannabis at week 24
Tidsramme: At 24 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline
Frequency of use of alcohol at week 4
Tidsramme: At 4 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of alcohol at week 12
Tidsramme: At 12 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of alcohol at week 24
Tidsramme: At 24 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Wake Forest University Health Sciences

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
National Institute on Drug Abuse (NIDA)

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Roger Vilardaga, PhD, Wake Forest University

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 (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
21. september 2021

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
30. december 2025

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
30. december 2025

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
26. august 2021

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
26. august 2021

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
1. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juli 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • IRB00110770
  • R01DA047301 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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 .

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