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- Essai clinique NCT00756275
Varenicline and Motivational Advice for Smokers With Substance Use Disorders (VARSUD)
Varenicline and Motivational Advice for Smokers With SUD
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Brown University, Center for Alcohol and Addiction Studies
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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.
Autres noms:
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.
Autres noms:
|
Comparateur actif: 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.
Autres noms:
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
7-day Point-prevalence Smoking Abstinence
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Length of Longest Continuous Abstinence
Délai: Weeks 9 to 12
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Weeks 9 to 12
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Percent Smoking Days
Délai: 3 month follow up
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3 month follow up
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Percent Smoking Days
Délai: 6 month follow up
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6 month follow up
|
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Percent Relapsed to Drug Use
Délai: 3 month follow up
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3 month follow up
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Percent Relapsed to Drug Use
Délai: 6 month follow up
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6 month follow up
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Percent Relapsed to Any Heavy Drinking
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Rosemarie Martin, Ph.D., Brown University
- Chercheur principal: Damaris J Rohsenow, Ph.D., Brown University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Troubles liés à une substance
- Trouble lié à l'usage du tabac
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents cholinergiques
- Stimulants ganglionnaires
- Agonistes nicotiniques
- Agonistes cholinergiques
- Nicotine
- Varénicline
Autres numéros d'identification d'étude
- 1R01DA024652 (Subvention/contrat des NIH des États-Unis)
- R01DA024652 (Subvention/contrat des NIH des États-Unis)
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