Long-term Behavior Change - 1
11. august 2015 opdateret af: Friends Research Institute, Inc.
Behavior Change: Reinforcement Schedule Effects
The purpose of this study is to determine if different reinforcement procedures (i.e., schedules) produce different patterns of long-term abstinence from methamphetamine.
We anticipate that the three contingency management conditions will promote longer periods of abstinence in the year following treatment relative to the standard control group.
Furthermore, we predict that the intermittent reinforcement procedures will produce longer periods of continued abstinence (i.e., long-term behavior change) in the year following treatment than the continuous reinforcement procedure.
Finally, we predict that the intermittent unpredictable schedule will produce longer lasting behavior change than the intermittent predictable schedule.
Methamphetamine use will be measured using urine toxicology and self-report of methamphetamine use.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Briefly the four study conditions are: (1) standard treatment which consists of 16 weeks of psychosocial treatment, (2) continuous contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are made available after each provision of a methamphetamine-negative urine test, (3) intermittent predictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available after the provision of every three consecutive methamphetamine-negative urine samples, and (4) intermittent unpredictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available on one day each week (randomly selected after the first week) for the provision of methamphetamine-negative urine samples provided all urine samples since delivery of the last reinforcer were also methamphetamine negative.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
119
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Los Angeles, California, Forenede Stater, 90025
- Friends Research Institute
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Rancho Cucamonga, California, Forenede Stater, 91730
- Friends Research Institute
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-
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence
- Willing and able to comply with study procedures
- Willing and able to provide written informed consent
Exclusion Criteria:
- Have a medical condition that, in the study Principal Investigator (PI's) judgment, might interfere with safe study participation
- Have a recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the Beck Depression Inventory (BDI)
- Have a history of violent criminal behavior or be on parole
- Any other circumstances that, in the opinion of the PI, would interfere with safe study participation
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: continuous voucher schedule
Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine.
The initial voucher value will be $2.50.
Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50.
Three consecutive abstinences will result in the delivery of a $10.00 bonus.
Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
|
Eksperimentel: intermittent predictable schedule
Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests.
Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth.
There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition.
Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
|
Eksperimentel: intermittent unpredictable schedule
Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week.
Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests.
They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative.
They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth.
The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
|
Ingen indgriben: standard
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Methamphetamine Use During Intervention
Tidsramme: 3x/week for 16 weeks
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Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
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3x/week for 16 weeks
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Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence
Tidsramme: 16 Weeks
|
Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual
|
16 Weeks
|
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Methamphetamine Use, Follow-Up
Tidsramme: 1x/month for 4 months
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Drug use measured by urine toxicology conducted by on site EMIT assay over time
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1x/month for 4 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John Roll, Ph.D., University of California, Los Angeles
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. december 2004
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
8. september 2005
Først indsendt, der opfyldte QC-kriterier
8. september 2005
Først opslået (Skøn)
12. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIDA-17407-1
- R01DA017407 (U.S. NIH-bevilling/kontrakt)
- R01-17407-1
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 .