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Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

2 maggio 2018 aggiornato da: Michael Stein, MD, Butler Hospital

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.

Secondary

  • To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
  • To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.

OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

  • Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
  • Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.

Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

315

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

  • Stati Uniti
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital Comprehensive Cancer Center

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 120 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

INCLUSION CRITERIA

  • Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)

  • Interested in quitting smoking

    • Willing to set a quit date 7 days after baseline assessment

  • Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:

    • Codac, Inc. (with two independent sites)
    • Addiction Recovery Institute
    • Center for Treatment and Recovery
    • Discovery House
  • Has received methadone for at least the past month

EXCLUSION CRITERIA

  • Pregnant or nursing (Must have negative pregnancy test)
  • Non-English speaking
  • No personal telephone or does not live close to a relative or neighbor with a telephone
  • Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
  • Unvailable for this study for the next 12 months
  • Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
  • Active skin condition (e.g., psoriasis)
  • History of skin allergy
  • History of a suicide attempt
  • Working as pilots, drivers, or operators of heavy machinery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent insulin or blood thinners
  • No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

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: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
Droga: varenicline
Given orally
Comparatore placebo: Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
Altro: placebo
Dato oralmente
Comparatore attivo: Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
Droga: nicotine
Given transdermally and orally

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self- Reported 7-day Abstinence
Lasso di tempo: 6 Months
Number of participants with self-reported, 7-day abstinence at 6-months
6 Months
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Lasso di tempo: 6-Months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
6-Months
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Lasso di tempo: 6-Months
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
6-Months
Self-reported 7-day Abstinence
Lasso di tempo: 12 Months
Number of participants with self-reported 7-day abstinence at 12-months
12 Months
CO-confirmed 7-day Abstinence
Lasso di tempo: 12 Months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
12 Months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Smoking Urges
Lasso di tempo: 6 months
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Withdrawal Symptoms
Lasso di tempo: 6 months
Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Retention in Methadone Maintenance
Lasso di tempo: 12 months
12 months
Methadone Dose Changes
Lasso di tempo: 12 months
12 months
Use of Illicit Drugs as Measured by Urine Toxicologies
Lasso di tempo: 12 months
12 months
Reinforcing Effects of Smoking
Lasso di tempo: 6 months
Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
6 months
Change in Cigarettes Per Day
Lasso di tempo: 6-Months
Change in mean cigarettes per day
6-Months

Collaboratori e investigatori

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

Sponsor

Butler Hospital

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Michael Stein, MD, Butler Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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

1 settembre 2008

Completamento primario (Effettivo)

1 ottobre 2012

Completamento dello studio (Effettivo)

1 ottobre 2012

Date di iscrizione allo studio

Primo inviato

11 novembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2008

Primo Inserito (Stima)

13 novembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000616663
  • R01CA129226 (Sovvenzione/contratto NIH degli Stati Uniti)
  • BUTLER-0807-004

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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