Varenicline and Motivational Advice for Smokers With Substance Use Disorders (VARSUD)
27. Juli 2018 aktualisiert von: Damaris J. Rohsenow, Ph.D., Brown University
Varenicline and Motivational Advice for Smokers With SUD
The purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared to nicotine replacement therapy for smoking cessation among outpatients in treatment for substance use disorders.
The intervention also incorporates counseling (Brief Advice), (adapted for sobriety settings), skills training and medication management.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
People with substance use disorders (SUD) have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. Brief advice (BA), to motivate cessation, produced some benefit but low abstinence rates for smokers with SUDs while adding free transdermal nicotine replacement therapy (NRT) improved short-term cessation rates. Varenicline has been found to produce higher rates of short and long-term abstinence than bupropion or placebo. However, a comparison between the efficacy of varenicline and NRT has not yet conducted with people with SUDs. Given the lack of effectiveness for standard smoking treatments for this population, what needs to be known is whether varenicline would increase the smoking abstinence rates relative to NRT when all receive motivational counseling.
The primary aim of this study is to evaluate the effects of 12 weeks of varenicline as compared to NRT, using a two-group randomized placebo-controlled design on smoking cessation rates for 12 months among 274 outpatients in treatment for SUD. The counseling incorporates BA (adapted slightly for sobriety settings by directly addressing barriers and concerns expressed by substance abusers), skills training and medication management. Confirmed point-prevalence and sustained abstinence will be assessed at 3 and 6 a months after the start of treatment. Secondary aims will examine potential mediators of effect including within-treatment abstinence, craving, and nicotine withdrawal levels.
The potential significance is to add to knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this difficult population. No study published to date has compared varenicline to NRT for efficacy with patients with SUD.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
158
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Brown University, Center for Alcohol and Addiction Studies
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Diagnosis of substance abuse or dependence by DSM-IV criteria
- Currently smoking at least 10 cigarettes per day for the past 6 months
Exclusion Criteria:
- Active psychosis or marked organic impairment according to medical records, or evidence of hallucinations or delusions
- Current use of any nicotine replacement, or other smoking cessation treatment
- Medical contraindications for NRT (including pregnancy, nursing, women not using birth control during heterosexual sex, history of unstable angina, history of severe congestive heart failure, uncontrolled hypertension, lung cancer, supplemental oxygen, allergy to adhesive, severe skin disease that requires treatment)
- Medical contraindications for VAR (including pregnancy, nursing, severe renal impairment by laboratory test, history of intolerance of varenicline, history of serious suicidal ideation or attempts in the past 5 years)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Nicotine Replacement + PLA pill
Nicotine replacement treatment patch plus matched placebo pill
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Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.
Andere Namen:
The counseling consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training.
Medication management is conducted in every session, smoking cessation pamphlets are available.
Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day.
Session 3 (10 min, in-person) will be 1 week later.
Sessions 4-10 will be 5-10 min.
telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.
Andere Namen:
|
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Aktiver Komparator: Varenicline + PLA patch
Varenicline plus matched placebo patches containing no nicotine
|
The counseling consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training.
Medication management is conducted in every session, smoking cessation pamphlets are available.
Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day.
Session 3 (10 min, in-person) will be 1 week later.
Sessions 4-10 will be 5-10 min.
telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.
Andere Namen:
Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows.
VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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7-day Point-prevalence Smoking Abstinence
Zeitfenster: 3 month follow up
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7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
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3 month follow up
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7-day Point-prevalence Smoking Abstinence
Zeitfenster: 6 month follow up
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7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.
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6 month follow up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Length of Longest Continuous Abstinence
Zeitfenster: Weeks 9 to 12
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Weeks 9 to 12
|
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Percent Smoking Days
Zeitfenster: 3 month follow up
|
3 month follow up
|
|
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Percent Smoking Days
Zeitfenster: 6 month follow up
|
6 month follow up
|
|
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Percent Relapsed to Drug Use
Zeitfenster: 3 month follow up
|
3 month follow up
|
|
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Percent Relapsed to Drug Use
Zeitfenster: 6 month follow up
|
6 month follow up
|
|
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Percent Relapsed to Any Heavy Drinking
Zeitfenster: 3 month follow up
|
6 or more drinks for men; 5 or more drinks for women
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3 month follow up
|
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Percent Relapsed to Any Heavy Drinking
Zeitfenster: 6 month follow up
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6 or more drinks for men; 5 or more drinks for women
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6 month follow up
|
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Beck Depression Inventory
Zeitfenster: Week 12
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0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression
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Week 12
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Rosemarie Martin, Ph.D., Brown University
- Hauptermittler: Damaris J Rohsenow, Ph.D., Brown University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19.
- Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available.
- Rohsenow DJ, Tidey JW, Martin RA, Colby SM, Swift RM, Leggio L, Monti PM. Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms. Addiction. 2017 Oct;112(10):1808-1820. doi: 10.1111/add.13861. Epub 2017 Jul 4.
- Murphy CM, MacKillop J, Martin RA, Tidey JW, Colby SM, Rohsenow DJ. Effects of varenicline versus transdermal nicotine replacement therapy on cigarette demand on quit day in individuals with substance use disorders. Psychopharmacology (Berl). 2017 Aug;234(16):2443-2452. doi: 10.1007/s00213-017-4635-4. Epub 2017 May 13.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2009
Primärer Abschluss (Tatsächlich)
1. März 2014
Studienabschluss (Tatsächlich)
1. September 2014
Studienanmeldedaten
Zuerst eingereicht
19. September 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. September 2008
Zuerst gepostet (Schätzen)
22. September 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. August 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Juli 2018
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Substanzbezogene Störungen
- Tabakkonsumstörung
- 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
- 1R01DA024652 (US NIH Stipendium/Vertrag)
- R01DA024652 (US NIH Stipendium/Vertrag)
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