Varenicline and Motivational Advice for Smokers With Substance Use Disorders (VARSUD)
27 juli 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
158
Fase
- Niet toepasbaar
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
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Brown University, Center for Alcohol and Addiction Studies
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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
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
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: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Actieve vergelijker: Varenicline + PLA patch
Varenicline plus matched placebo patches containing no nicotine
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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7-day Point-prevalence Smoking Abstinence
Tijdsspanne: 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
Tijdsspanne: 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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Length of Longest Continuous Abstinence
Tijdsspanne: Weeks 9 to 12
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Weeks 9 to 12
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Percent Smoking Days
Tijdsspanne: 3 month follow up
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3 month follow up
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Percent Smoking Days
Tijdsspanne: 6 month follow up
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6 month follow up
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Percent Relapsed to Drug Use
Tijdsspanne: 3 month follow up
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3 month follow up
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Percent Relapsed to Drug Use
Tijdsspanne: 6 month follow up
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6 month follow up
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Percent Relapsed to Any Heavy Drinking
Tijdsspanne: 3 month follow up
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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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Rosemarie Martin, Ph.D., Brown University
- Hoofdonderzoeker: Damaris J Rohsenow, Ph.D., Brown University
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.
Algemene publicaties
- 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.
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 2009
Primaire voltooiing (Werkelijk)
1 maart 2014
Studie voltooiing (Werkelijk)
1 september 2014
Studieregistratiedata
Eerst ingediend
19 september 2008
Eerst ingediend dat voldeed aan de QC-criteria
19 september 2008
Eerst geplaatst (Schatting)
22 september 2008
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 augustus 2018
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2018
Laatst geverifieerd
1 juli 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Chemisch veroorzaakte aandoeningen
- Middelgerelateerde aandoeningen
- Tabaksgebruiksstoornis
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Cholinerge middelen
- Ganglionische stimulerende middelen
- Nicotine-agonisten
- Cholinerge agonisten
- Nicotine
- Varenicline
Andere studie-ID-nummers
- 1R01DA024652 (Subsidie/contract van de Amerikaanse NIH)
- R01DA024652 (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 .
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