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- Klinische proef NCT01334736
A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
17 augustus 2017 bijgewerkt door: Johns Hopkins University
Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases.
Quitting smoking is proven to improve the health of people addicted to cigarettes. .
Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking.
Additionally, most programs designed to help people quit smoking are not very successful.
One reason these programs may not work well is because it is difficult to motivate people to quit smoking.
New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results.
For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old".
In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking.
The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins ALIVE Clinic
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Active smoker
Exclusion Criteria:
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Gebruikelijke zorg
|
After participants have completed the data collection portion of the SHIELD visit, the research assistant will provide the participant with an informational flyer regarding the risks of tobacco smoking and benefits of tobacco cessation.
The participant will be provided the phone number for the Tobacco Quit Line in Maryland as well as a list of local tobacco cessation programs.
Any questions will be answered by the research assistant.
If the participant inquires about nicotine replacement therapy, they will be advised to contact their primary care provider to discuss potential therapeutic options.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
|
Actieve vergelijker: Lung Age
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For individuals randomized to spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be verbally informed of spirometric results.
It will be explained that lung function normally reduces with age and that smoking can damage lung as if they were aging more rapidly than normal using visual depictions.
Their lung function estimates based on their chronological age and lung age will be provided.
They will be informed that smoking cessation would slow the aging of their lungs.
After questions are answered, the participant will receive a written report that includes enumeration of their lung age and chronological age.
At initial and follow-up visits, the research assistant will provide the participant with the same informational flyer and Tobacco Quit Line in Maryland as the usual care intervention.
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Actieve vergelijker: Contingency Management
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For individuals randomized to CM, after completion of data collection, it will be explained to the participant that they will receive monetary compensation for biological confirmation of tobacco cessation.
At each visit, exhaled carbon monoxide levels will be checked.
If the subject has a negative CO level, they will be compensated.
If a participant has a CO consistent with recent tobacco use, (s)he will receive the payment for attending the visit, but no additional payment at that visit.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
|
Actieve vergelijker: Lung age + Contingency Management
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For individuals randomized to the combined contingency management + spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be described the process of contingency management as outlined above.
Following this, the research assistant will then describe lung age to the participant as described above.
At the end of this process, the participant will then receive the informational flyer, quit line and local tobacco cessation program information similar to the usual care intervention.
At each follow-up visit, after obtaining CO level and questionnaire outcomes, appropriate CM payment, review of participant's baseline lung age and informational flyer will occur.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Biologically confirmed tobacco cessation
Tijdsspanne: 6 months
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The primary outcome will be validated tobacco cessation at 6 months.
Biologically confirmed tobacco cessation will be assessed by self-report of smoking status combined with CO measurement.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Self efficacy and intention to quit
Tijdsspanne: 6 months
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Self-efficacy and intention to quit smoking will be assessed at baseline using a modified version of the Prochaska stages of change questionnaire.
Quit attempts will be enumerated at follow-up visits by asking participants how many quit attempts they made in the prior six months.
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6 months
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Cessation attempts
Tijdsspanne: 6 months
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Cessation attempts will be quantified as the number of sustained cessation attempts lasting more than 7 days, number of sustained cessation attempts lasting more than one month and number of daily cigarettes smoked.
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6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 april 2011
Primaire voltooiing (Werkelijk)
1 juli 2012
Studie voltooiing (Werkelijk)
1 juli 2012
Studieregistratiedata
Eerst ingediend
12 april 2011
Eerst ingediend dat voldeed aan de QC-criteria
12 april 2011
Eerst geplaatst (Schatting)
13 april 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TD-10-002
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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