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Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

15 août 2019 mis à jour par: MPRC, University of Maryland, Baltimore

In this study, we will compare cue-reactivity in smokers with and without schizophrenia and the influence of smoking cues on responding for cigarette puffs under a PR schedule of reinforcement. Given the high prevalence of smoking among individuals with schizophrenia, understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes. Establishing and validating a laboratory model of cue-elicited responsivity and cigarette self- administration will allow the investigation of the efficacy of anti-craving medications in people with schizophrenia.

Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco cigarettes in smokers with schizophrenia and smokers without schizophrenia.

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with level of nicotine dependence, various smoking behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures with the 3-HC/cotinine ratio to explore possible relationships for future study.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

44

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Maryland
      • Catonsville, Maryland, États-Unis, 21228
        • Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 64 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

  • Inclusion Criteria for Schizophrenia Patients

    1. 18-64 year old males and females
    2. Smoking at least 10 cigarettes per day for at least 1 year
    3. Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
    4. Current DSM-IV diagnosis of schizophrenia and stable medication regimen (see above)
    5. Medically healthy as determined by screening criteria

  • Inclusion Criteria for Healthy Volunteers

    1. 18-64 year old males and females
    2. Smoking at least 10 cigarettes per day for at least 1 year
    3. Urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
    4. Medically and psychologically healthy as determined by screening criteria

  • Exclusion Criteria for Schizophrenia Patients

    1. Current interest in reducing or quitting tobacco use
    2. Treatment for tobacco dependence in the past 3 months
    3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
    4. Consumption of more than 15 alcoholic drinks per week during the past month
    5. Use of any illicit drug more than twice per week during the past month
    6. Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, first-generation antipsychotics, and mood stabilizers)
    7. Under the influence of a drug or alcohol at experimental sessions
    8. Pregnant, nursing, or become pregnant during the study

  • Exclusion Criteria for Healthy Volunteers

    1. Current interest in reducing or quitting tobacco use
    2. Treatment for tobacco dependence in the past 3 months
    3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
    4. Consumption of more than 15 alcoholic drinks per week during the past month
    5. Use of any illicit drug more than twice per week during the past month
    6. Current use of any medication that would interfere with the protocol in the opinion of MAI (e.g., medications that would interfere with the cue reactivity portion of the study including, but not limited to, antidepressants, antipsychotics, and mood stabilizers)
    7. Under the influence of a drug or alcohol at experimental sessions
    8. Pregnant, nursing, or become pregnant during the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cues
Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).
Comportemental: Smoking Cues
In the smoking cue condition, a pack of the participants preferred brand of cigarettes, a lighter, and an ashtray will be under the tray cover. In the neutral cue condition, a pack of unsharpened pencils, a pencil sharpener, and a small notepad will be under the cover. When instructed, the participant will lift the cover on the tray. In the smoking cue condition, participants will take one cigarette out of the pack, light it without puffing, hold it for 1 minute, extinguish the cigarette, and replace the cover on the tray.
Comportemental: Neutral Cues
In the neutral cue condition, participants will take one pencil out of the pack, sharpen it, hold it for 1 minute as if to write on the notepad, and then replace the cover. Participants will complete the VAS during cue exposure and the TCQ-SF, VAS, and mood form immediately and 15 minutes after cue presentation; physiological measures will be recorded continuously.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.
Délai: 7-10 Days
7-10 Days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Maryland, Baltimore

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: Stephen J Heishman, Ph.D., National Institute on Drug Abuse (NIDA)
  • Chercheur principal: Deanna L Kelly, Pharm.D, BCPP, University of Maryland, College Park

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2008

Achèvement primaire (Réel)

1 décembre 2010

Achèvement de l'étude (Réel)

1 décembre 2010

Dates d'inscription aux études

Première soumission

7 octobre 2008

Première soumission répondant aux critères de contrôle qualité

8 octobre 2008

Première publication (Estimation)

9 octobre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2019

Dernière vérification

1 août 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HP-00042356
  • NIDA 430

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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