Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

4 settembre 2018 aggiornato da: Nina A. Copperman, Psy. D., Rutgers, The State University of New Jersey

The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Quitline). The newly developed intervention is evidence based, addresses the unique needs of methadone maintained smokers, is intensive, can be tailored to the individual, and builds on the strengths as well as addresses the gaps in previous treatments for methadone maintained smokers.

The investigators hypothesize that: (1) three months and six months after beginning treatment, those in the tailored intervention condition will be more likely to be abstinent from smoking than those in the control intervention condition (primary outcome); (2) there will be a greater relapse rate in the control intervention condition between the three and six month follow-up points than in the tailored intervention condition; (3) three and six months after beginning treatment, those in the tailored intervention condition will have better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week, be more ready to quit, have greater self-efficacy for quitting, experience less nicotine dependence, and be more likely to have made a quit attempt) than those in the control intervention condition; (4) three and six months after beginning treatment, those in the tailored intervention condition will have better utilization of and adherence to smoking cessation pharmacotherapy, better mental and physical health, less perceived stress, greater social support, less drug and alcohol use, and greater involvement in drug and alcohol treatment than those in the control intervention condition; and (5) the newly created tailored intervention will be feasible and acceptable. .

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Most individuals in methadone maintenance treatment are tobacco smokers. Also, people in methadone treatment are more likely to experience the health issues related to smoking than the general population. Yet, research has found that smokers receiving methadone treatment are interested in quitting and receiving tobacco cessation treatment, and people in drug treatment who quit smoking are less likely to use drugs.

To better help methadone maintained smokers quit smoking and prevent them from starting smoking again, we want to evaluate the effects of a new smoking cessation counseling intervention, designed for methadone maintained smokers as compared to a smoking cessation counseling intervention used with the general population.

Eligible participants will:

  • Be English speaking (i.e., able to participate in counseling sessions in English and to complete study interviews in English);
  • Be enrolled in methadone treatment for at least three months;
  • Be able to give informed consent;
  • Be willing and able to participate in all study activities;
  • Not have taken smoking cessation related medication or participated in smoking cessation counseling in the past six months;
  • Have smoked at least 100 cigarettes during their lifetime and currently smoke every day or most days;
  • Not currently be pregnant or breastfeeding or plan on getting pregnant or breastfeeding during the next six months;
  • Have access to a working telephone; and,
  • Be interested in participating in a smoking cessation intervention and quitting smoking within the next six months.

Participants will be randomly assigned to receive either a smoking cessation intervention tailored for methadone maintained smokers or a referral to a smoking cessation program available to the general population (NJ Quitline). Participants assigned to receive the tailored intervention, will participate in approximately eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the participant's methadone clinic. Treatment needs will be assessed during the first session and the intervention will be tailored to participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.

Study staff will contact the NJ Quitline for participants assigned to the control condition, and a counselor from the Quitline will call them.

Regardless of treatment assignment, participants will be asked to provide a urine sample for a drug test and pregnancy test (for women) and complete an interview, using a computer or face-to-face, before beginning treatment or receiving the NJ Quitline referral and three months and six months after study enrollment.Each interview will take approximately 45 minutes to one hour to complete.

Participants will receive a $20 gift card for completing each research visit (i.e., computer or face-to-face interview), but will not be reimbursed for counseling visits.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

87

Fase

  • Fase 1

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
    • New Jersey
      • New Brunswick, New Jersey, Stati Uniti, 08901
        • Rutgers Robert Wood Johnson Medical School

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Enrolled in methadone treatment for at least three months
  • Able to give informed consent
  • Willing and able to participate in all study activities
  • Smoked at least 100 cigarettes during their lifetime
  • Currently smoke every day or most days
  • Has access to a working telephone
  • Interested in participating in a smoking cessation intervention and quitting smoking within the next six months

Exclusion Criteria:

  • Unable to speak English fluently
  • Took smoking cessation related medication or participated in smoking cessation counseling in the past three months
  • Pregnant or breastfeeding or planning on becoming pregnant or breastfeeding during the next six months

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intensive, tailored intervention
Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.
Comportamentale: Intensive, tailored intervention
Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.
Altri nomi:
  • Smokers in Methadone Treatment Intervention
  • IMB Model Based Smoking Cessation Intervention
Comparatore attivo: Control Intervention
Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.
Comportamentale: NJ Quitline Referral
Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Altri nomi:
  • Standard of Care Smoking Cessation Intervention
  • General Population Smoking Cessation Intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence
Lasso di tempo: during the previous seven days at three months post baseline
Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million.
during the previous seven days at three months post baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Median Number of Cigarettes Participants Smoked Per Day During the Past Week
Lasso di tempo: during the previous seven days at three months post baseline
Self-reported, median number of cigarettes per day during the previous seven days
during the previous seven days at three months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Baseline
Lasso di tempo: During the period between baseline and three months post enrollment
Self-reported, smoke free for 24 hours or more since baseline (yes/no)
During the period between baseline and three months post enrollment
Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence
Lasso di tempo: during the previous seven days at six months post baseline
Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million.
during the previous seven days at six months post baseline
Median Number of Cigarettes Smoked Per Day During the Past Week
Lasso di tempo: during the previous seven days at six months post baseline
Self-reported, median number of cigarettes per day during the previous seven days
during the previous seven days at six months post baseline
Number of Participants Who Experienced Any Quit Attempts Since Enrollment
Lasso di tempo: during the period between baseline and six months post-enrollment
Self-reported, smoke free for 24 hours or more since baseline (yes/no)
during the period between baseline and six months post-enrollment

Collaboratori e investigatori

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

Sponsor

Rutgers, The State University of New Jersey

Collaboratori

National Institute on Drug Abuse (NIDA)

Investigatori

  • Investigatore principale: Nina Cooperman, Psy.D., Rutgers Robert Wood Johnson Medical School

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 ottobre 2011

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

1 maggio 2014

Date di iscrizione allo studio

Primo inviato

27 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

11 luglio 2011

Primo Inserito (Stima)

13 luglio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • K23DA025049 (Sovvenzione/contratto NIH degli Stati Uniti)

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 .

Prove cliniche su Intensive, tailored intervention

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Italy

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi