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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 agosto 2019 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Anticipato)

44

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Maryland
      • Catonsville, Maryland, Stati Uniti, 21228
        • Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.
Lasso di tempo: 7-10 Days
7-10 Days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2008

Completamento primario (Effettivo)

1 dicembre 2010

Completamento dello studio (Effettivo)

1 dicembre 2010

Date di iscrizione allo studio

Primo inviato

7 ottobre 2008

Primo inviato che soddisfa i criteri di controllo qualità

8 ottobre 2008

Primo Inserito (Stima)

9 ottobre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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