- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00790569
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.
Secondary
- To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
- To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.
OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.
At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.
- Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
- Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).
NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.
PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Rhode Island
-
Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
INCLUSION CRITERIA
- Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
Interested in quitting smoking
- Willing to set a quit date 7 days after baseline assessment
Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
- Codac, Inc. (with two independent sites)
- Addiction Recovery Institute
- Center for Treatment and Recovery
- Discovery House
- Has received methadone for at least the past month
EXCLUSION CRITERIA
- Pregnant or nursing (Must have negative pregnancy test)
- Non-English speaking
- No personal telephone or does not live close to a relative or neighbor with a telephone
- Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
- Unvailable for this study for the next 12 months
- Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
- Active skin condition (e.g., psoriasis)
- History of skin allergy
- History of a suicide attempt
- Working as pilots, drivers, or operators of heavy machinery
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent insulin or blood thinners
- No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
|
Given orally
|
Placebo-Komparator: Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
|
Mündlich gegeben
|
Aktiver Komparator: Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks.
Patients also receive nicotine gum to quell breakthrough urges.
Patients may stop treatment when a comfortable level of smoking abstinence is reached.
|
Given transdermally and orally
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Self- Reported 7-day Abstinence
Zeitfenster: 6 Months
|
Number of participants with self-reported, 7-day abstinence at 6-months
|
6 Months
|
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Zeitfenster: 6-Months
|
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
|
6-Months
|
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Zeitfenster: 6-Months
|
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
|
6-Months
|
Self-reported 7-day Abstinence
Zeitfenster: 12 Months
|
Number of participants with self-reported 7-day abstinence at 12-months
|
12 Months
|
CO-confirmed 7-day Abstinence
Zeitfenster: 12 Months
|
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
|
12 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Smoking Urges
Zeitfenster: 6 months
|
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale.
Higher values represent greater urge to smoke.
Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
|
6 months
|
Withdrawal Symptoms
Zeitfenster: 6 months
|
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale.
The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe).
Higher values indicate more severe withdrawal symptoms.
Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
|
6 months
|
Retention in Methadone Maintenance
Zeitfenster: 12 months
|
12 months
|
|
Methadone Dose Changes
Zeitfenster: 12 months
|
12 months
|
|
Use of Illicit Drugs as Measured by Urine Toxicologies
Zeitfenster: 12 months
|
12 months
|
|
Reinforcing Effects of Smoking
Zeitfenster: 6 months
|
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire.
Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely).
Higher values indicated that smoking was a more positive experience for 10 of 12 items.
Two items were reverse coded.
Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
|
6 months
|
Change in Cigarettes Per Day
Zeitfenster: 6-Months
|
Change in mean cigarettes per day
|
6-Months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Michael Stein, MD, Butler Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14.
- de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764.
- Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- nicht-kleinzelligem Lungenkrebs
- Speiseröhrenkrebs
- Blasenkrebs
- Magenkrebs
- Bauchspeicheldrüsenkrebs
- Nierenzellkarzinom
- kleinzelliger lungenkrebs
- Gebärmutterhalskrebs
- Oropharynx-Krebs
- Kehlkopfkrebs
- Hypopharynx-Krebs
- primärer Leberkrebs bei Erwachsenen
- Lippen- und Mundhöhlenkrebs
- Nasen-Rachen-Krebs
- Nasennebenhöhlen- und Nasenhöhlenkrebs
- akute myeloische Leukämie bei Erwachsenen
- Tabakkonsumstörung
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Erkrankungen des Verdauungssystems
- Substanzbezogene Störungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Urologische Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Urologische Erkrankungen
- Erkrankungen der Harnblase
- Uterusneoplasmen
- Genitale Neubildungen, weiblich
- Gebärmutterhalskrankheiten
- Uteruserkrankungen
- Erkrankungen des endokrinen Systems
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Magenerkrankungen
- Neoplasmen der endokrinen Drüse
- Leberkrankheiten
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Erkrankungen der Bauchspeicheldrüse
- Gebärmutterhalstumoren
- Magenneoplasmen
- Lungentumoren
- Tabakkonsumstörung
- Neoplasien der Harnblase
- Neoplasmen der Bauchspeicheldrüse
- Lebertumoren
- Ösophagusneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Cholinerge Wirkstoffe
- Ganglionäre Stimulanzien
- Nikotin-Agonisten
- Cholinerge Agonisten
- Nikotin
- Vareniclin
Andere Studien-ID-Nummern
- CDR0000616663
- R01CA129226 (US NIH Stipendium/Vertrag)
- BUTLER-0807-004
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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