Enhancing Smoking Cessation in the Homeless Population
17 november 2020 bijgewerkt door: University of Minnesota
The goal of this research study is to enhance smoking cessation rates for homeless smokers.
The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses.
The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC).
Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed.
The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC).
The study length is reduced to 26 weeks from 52 weeks.
All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.
Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months.
Both study conditions will have equal number of study contacts.
Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled.
Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26.
Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26.
Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board.
Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St.
Paul metro area.
Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. Having alcohol treatment added to the smoking intervention will enable us assess whether addressing alcohol abuse will result in improved smoking abstinence, an important scientific question that has never been studied in homeless populations.
Study conditions: Both study conditions have identical number of contacts; we considered a design in which the duration of counseling in the UC will be identical to those in the IS+A condition but decided against this because it will create a usual care condition that exceeds standard practice for brief interventions. We understand that testing hypothesis 3 confounds contact time with treatment content, and hence we will not be able to determine that observed differences in outcome are due to specific treatment components. However, given the current state of knowledge about treating homeless alcohol abusing smokers, we believe it is sufficient to show that our intervention led to improved outcome in this group without knowing if the finding is due to specific intervention content. Subsequent research will be needed to disentangle various intervention components.
All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by study data collection visits for 3 months. Each participant will be randomly assigned to a condition, which will dictate their treatment. Each participant will be asked to engage in the therapy assigned to their condition, and work to quit smoking and consuming alcohol over a period of one year.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
352
Fase
- Fase 4
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
-
-
Minnesota
-
Minneapolis, Minnesota, Verenigde Staten, 55414
- University of Minnesota
-
-
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 tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Currently Homeless
- Smoked at least 100 cigarettes in lifetime
- AUDIT score of > or equal to 5, < or equal to 26
- Aged 18 years or older
- Willing to attend study sessions and follow other study protocol
Exclusion Criteria:
- Use of smoking cessation medications or interventions in last 30 days
- Unstable medical illness that requires immediate medical care
- AUDIT score of < 5 or > 26
- Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
- Current history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months
- Cognitive impairment
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: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Integrated Intensive Smoking + Alcohol
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge.
An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
|
12-week treatment with nicotine patch plus nicotine gum/lozenge
Andere namen:
Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
Andere namen:
|
|
Placebo-vergelijker: Usual Care
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
|
12-week treatment with nicotine patch plus nicotine gum/lozenge
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
CO-verified Smoking Status at 26 Weeks
Tijdsspanne: 7-day smoking abstinence at week 26 follow-up
|
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air.
Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
|
7-day smoking abstinence at week 26 follow-up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
CO-verified Smoking Status at 12 Weeks
Tijdsspanne: at weeks 12
|
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air.
Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
|
at weeks 12
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Self-Reported Continuous Alcohol Abstinence for 30 Days
Tijdsspanne: at week 26
|
Participants will use a self-administered timeline-followback instrument, which asks them to retrospectively estimate their alcohol use in the 30 days prior to the report date.
Outcome is reported as the mean number of continuous alcohol-free days over the past 30 day period.
|
at week 26
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Pratt Rebekah, PhD, University of Minnesota
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.
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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
1 januari 2015
Primaire voltooiing (Werkelijk)
31 oktober 2018
Studie voltooiing (Werkelijk)
31 oktober 2018
Studieregistratiedata
Eerst ingediend
27 augustus 2013
Eerst ingediend dat voldeed aan de QC-criteria
27 augustus 2013
Eerst geplaatst (Schatting)
30 augustus 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 november 2020
Laatste update ingediend die voldeed aan QC-criteria
17 november 2020
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1307M39761
- 2R01HL081522-05A1 (Subsidie/contract van de Amerikaanse NIH)
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 .