- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00865254
Prize Reinforcement for Smoking Cessation
27. juni 2013 opdateret af: David Ledgerwood, Wayne State University
Nicotine dependence is prevalent in society, cigarette smoking is associated with several known health risks, and most dependent individuals find it very difficult to stop smoking cigarettes.
The present study will test the efficacy of a behavioral smoking cessation treatment, prize-based contingency management, that has not undergone rigorous study with respect to smoking, it but has demonstrated efficacy in reducing use of other substances (e.g.
cocaine).
If efficacious, prize-based contingency management would add to our repertoire of efficacious smoking cessation treatments.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Contingency management (CM) treatments are efficacious in reducing substance use.
A relatively new approach, called prize-based CM, which uses prizes to reinforce substance abstinence, is effective in decreasing certain types of substance use, but its efficacy has not been evaluated in the treatment of cigarette smoking.
One purpose of the current study is to assess the efficacy of a prize reinforcement intervention for reducing cigarette smoking.
A second purpose is to test the differential efficacy of two schedules of reinforcement, using cigarette smoking as an exemplar.
We will randomly assign 110 patients to one of three conditions: 1) Standard treatment; 2) Traditional prize reinforcement; or 3) Early-treatment enhanced prize reinforcement.
Patients in each condition will receive counseling for their smoking based on current standard of care guidelines.
All patients will participate in a one-week baseline period, followed by a four-week intervention.
Throughout both phases, each patient will meet with a research assistant twice daily to provide carbon monoxide (CO) samples.
Patients in the prize reinforcement conditions will earn the chance to win prizes when they provide negative CO samples (i.e., < 6ppm).
They will also earn bonus draws if they provide negative cotinine samples (i.e., <100ng/ml) after weekends.
Patients in the Traditional CM condition will have at least a 50% chance of winning a prize for each negative sample with escalating chances for successive negative samples.
Patients in the Enhanced condition will have the opportunity to earn the same overall number of draws and magnitude of reinforcement, but the schedule of reinforcement will differ.
For the first week of the CM phase, these patients will have a 100% chance of winning prizes, but in the latter 3 weeks, overall probability of reinforcement will be decreased to 34%.
Patients will also undergo 2- and 6-month follow-up assessments.
Primary outcome measures will be longest duration of continuous abstinence and mean number of days of abstinence.
We predict that the prize reinforcement will reduce cigarette smoking to a greater extent than standard treatment.
We also predict that the Enhanced CM condition will lead to greater reductions in cigarette smoking relative to the Traditional CM condition, and that these changes may result in longer sustained abstinence from smoking throughout the study period.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48207
- Wayne State University, Jefferson Avenue Research Clinic
-
-
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
13 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- A current Fagerstrom scale score of 6 or greater;
- Age 13 years old or older (Under age 18, parental consent is required);
- Able to read and understand English.
Exclusion Criteria:
- Have current severe, uncontrolled psychiatric disorders (i.e., acute suicidality or psychosis);
- Have current substance dependence, other than nicotine or caffeine dependence;
- Are in recovery for pathological gambling; or
- Are already participating in other behavioral or medication smoking cessation programs.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Traditional Contingency Management
Standard treatment plus prize based contingency management.
|
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Prize draws result in incentives on an intermittent schedule (50% of draws are prizes).
Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
|
|
Eksperimentel: Early Enhanced Contingency Management
Prize based contingency management with enhanced magnitude early in treatment and reduced magnitude later in treatment.
|
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Prize draws result in incentives on an intermittent schedule (100% of draws are prizes in week 1; 33% are prizes in weeks 2-4).
Participants are also provided with brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
|
|
Aktiv komparator: Standard Treatment
Counseling and monitoring of smoking cessation.
|
Brief counseling for smoking cessation followed by continued brief supportive sessions and frequent monitoring of smoking cessation efforts.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Expired Carbon Monoxide
Tidsramme: Baseline and treatment phases, 2-mont and 6-month follow up.
|
Baseline and treatment phases, 2-mont and 6-month follow up.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Self-reported smoking.
Tidsramme: Baseline, throughout treatment, 2-month and 6-month follow up.
|
Baseline, throughout treatment, 2-month and 6-month follow up.
|
|
Cotinine levels.
Tidsramme: Baseline, throughout treatment, 2-month and 6-month follow up.
|
Baseline, throughout treatment, 2-month and 6-month follow up.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David M Ledgerwood, Ph.D., Wayne State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. august 2007
Primær færdiggørelse (Faktiske)
1. juli 2011
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
17. marts 2009
Først indsendt, der opfyldte QC-kriterier
17. marts 2009
Først opslået (Skøn)
19. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RDA021839A
- R21DA021839 (U.S. NIH-bevilling/kontrakt)
- 1R21DA021839-01 (U.S. NIH-bevilling/kontrakt)
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 Traditional Contingency Management
-
Transcendent International, LLCMOUNT SINAI HOSPITALAfsluttet
-
Duke UniversityAfsluttetCannabis | Brug af cannabisForenede Stater
-
BrightView LLCDynamiCare Health; Interact for HealthUkendtTobaksbrugsforstyrrelse | StofbrugsforstyrrelserForenede Stater
-
Fordham UniversityAlbert Einstein College of Medicine; University of Texas at Austin; William...AfsluttetRygestopForenede Stater
-
Wake Forest University Health SciencesUniversity of California, Berkeley; University of ChicagoAfsluttetStof-relaterede lidelser | Opioid-relaterede lidelser | AdfærdsterapiForenede Stater
-
Oregon Social Learning CenterAfsluttet
-
Yale UniversityThe Hospital for Sick Children; United States Department of Defense; Connecticut...AfsluttetKronisk smerte | Neurofibromatose 1Forenede Stater
-
Hospital Clinic of BarcelonaUkendtMisbrug af marihuanaSpanien
-
University of California, Los AngelesAfsluttetHIV/AIDSForenede Stater
-
VA Office of Research and DevelopmentAktiv, ikke rekrutterendePTSD | Cannabis-relateret lidelseForenede Stater