- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04461288
Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Přehled studie
Postavení
Detailní popis
Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).
Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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California
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San Francisco, California, Spojené státy, 94143
- University of California, San Francisco
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Daily smoker
- Self-identify as sexual and/or gender minority
- Interested in quitting in next 6 months
- 6 months of Facebook experience
- English-speaking
Exclusion Criteria:
- Contraindications to nicotine replacement therapy
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 |
|---|---|
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Experimentální: Pride Posts
This six month intervention will be conducted on the Facebook platform.
Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+).
Weekly live sessions with a tobacco expert will be available.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
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Experimentální: Pride Posts Plus
This six month intervention will include all elements of the Pride Posts arm.
In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.
Gaming elements designed to encourage participation in the program and behavior change.
|
|
Aktivní komparátor: Usual Care Condition
Participants in this arm will be provided with a referral to smokefree.gov,
a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
Časové okno: 3 months
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Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.
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3 months
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Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
Časové okno: 6 months
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Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Časové okno: 3 to 6 months
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Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
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3 to 6 months
|
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Responses to the Thoughts About Abstinence Questionnaire Over Time
Časové okno: 3 to 6 months
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The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.
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3 to 6 months
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Frequency of social media posts
Časové okno: 3 to 6 months
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Treatment engagement as measured by frequency of social media posts
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3 to 6 months
|
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Frequency of participation in live group sessions
Časové okno: 3 to 6 months
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Treatment engagement as measured by participation in live group sessions
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3 to 6 months
|
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Duration of Active Participation
Časové okno: 3 to 6 months
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Treatment engagement as measured by duration of active participation in intervention.
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3 to 6 months
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gary Humfleet, PhD, University of California, San Francisco
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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- Molekulární mechanismy farmakologického působení
- Autonomní agenti
- Agenti periferního nervového systému
- Cholinergní činidla
- Ganglionové stimulanty
- Nikotinoví agonisté
- Cholinergní agonisté
- Nikotin
Další identifikační čísla studie
- TRDRP - T29IP0461
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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