- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01932996
Enhancing Smoking Cessation in the Homeless Population
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55414
- University of Minnesota
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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
Ostatní jména:
Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
Ostatní jména:
|
Komparátor placeba: 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
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12-week treatment with nicotine patch plus nicotine gum/lozenge
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
CO-verified Smoking Status at 26 Weeks
Časové okno: 7-day smoking abstinence at week 26 follow-up
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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.
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7-day smoking abstinence at week 26 follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
CO-verified Smoking Status at 12 Weeks
Časové okno: at weeks 12
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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.
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at weeks 12
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Self-Reported Continuous Alcohol Abstinence for 30 Days
Časové okno: at week 26
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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.
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at week 26
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Pratt Rebekah, PhD, University of Minnesota
Publikace a užitečné odkazy
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- 1307M39761
- 2R01HL081522-05A1 (Grant/smlouva NIH USA)
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