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Bupropion for Hospital-Based Smoking Cessation

22. maj 2008 opdateret af: University of California, San Francisco
This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Two hundred and seventy patients will be enrolled;approximately 135 will be randomized to each study arm over the course of 24 months. Patients will be considered smokers if they have used tobacco products during the week prior to admission and if they have smoked> or = 5 cigarettes /day during the previous year.Smokers will be identified by review of admissions and given a flyer to invite them to join the study. Interested smokers will be screened and asked to fill out a Beck Depression Inventory. Patients with very high Beck Depression Inventory Scores, i.e. > or = 30, will not be enrolled because such individuals may require other treatment. Each patient's physician will be contacted to verify his/her eligibility for the study. Once eligibility has been ascertained, a research associate will visit the patient to obtain informed consent and to enroll them in the study. Study questionnaires and a Fagerstrom test for Nicotine Dependence will be completed and reviewed by a research associate for completeness at the time of enrollment. The associate will put in the prescription for the study drug and request the order for dispensing of the drug. The research pharmacist will randomize the patient to Study Arm 1 or Study Arm 2.

Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion (150 mg/day for the first 3 days, then 150mg BID), a self-help booklet, counseling on smoking cessation strategies, and follow-up phone counseling during the first 3 months after randomization. Study Arm 2 participants will receive the same intervention as Study Arm 1, but will receive placebo instead of active bupropion therapy. Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects.

Since quit rates tend to decline over time, relapse prevention approaches will be included in both study arms. Marlatt's theory of relapse, an extension of Bandura's social learning model, will be used to augment the quitter's perception of self-efficacy. Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital. Behavioral self-management techniques to counter known relapse-triggers such as stress, the presence of other smokers, alcohol use and depression will be discussed during follow-up counseling calls.

We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months. Cotinine levels of > or + 15 ng/mL will be considered evidence of current tobacco use. Participants who are self-reported quitters, but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained. Participants who have died will be analyzed as smokers or quitters based on prior self-report, information in medical records, or interviews with next-of-kin. Others will be censored (i.e. excluded from the analysis). All cotinine samples will be assayed at the University of California, San Francisco,laboratory of Dr. Neal Benowitz.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

85

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • San Francisco, California, Forenede Stater, 94121
        • Veterans Affairs Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • currently smoking - use of tobacco products during the week prior to hospital admission and having smoked at least 5 cigarettes /day during the past year
  • eligibility to receive medical care in a VA hospital
  • hospitalization for at least 48 hours to provide sufficient time to identify, screen, enroll and counsel participants
  • willingness to participate and give informed consent

Exclusion Criteria:

  • hospitalization for acute CHD syndromes
  • contraindications to the use of bupropion
  • family history of seizure disorder, history of severe head trauma, predisposition to seizures
  • unstable psychiatric disorder
  • pregnancy, lactation
  • current alcohol (defined as greater than 3 drinks/day) or drug abuse (defined as current/within last 3 months use of narcotics, heroin, cocaine, amphetamines)
  • current untreated depression (BDI score > or = 30)
  • terminal illness
  • inability to be contacted by phone

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
bupropion and behavioral counseling
150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
Andre navne:
  • Zyban
Placebo komparator: 2
placebo medication
1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
Andre navne:
  • sukker pille

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Smoking status at 6 months after enrollment
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
smoking status at end of treatment
Tidsramme: 7 weeks
7 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Joel A Simon, MD, MPH, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2003

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. februar 2007

Datoer for studieregistrering

Først indsendt

1. december 2005

Først indsendt, der opfyldte QC-kriterier

1. december 2005

Først opslået (Skøn)

2. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. maj 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2008

Sidst verificeret

1. maj 2008

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med bupropion

3
Abonner