Comparison of Two Counseling Induction Strategies
16. september 2015 oppdatert av: Michael Kidorf, Johns Hopkins University
Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance
New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on methadone and randomly assigned to one of two induction conditions: 1) routine stepped care, or 2) low threshold stepped care.
All participants will continue with routine stepped care in month 4. Treatment retention is the primary outcome measure, while drug use (measured via weekly urinalysis testing) is the major secondary outcome.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This randomized clinical trial will evaluate two induction strategies for helping out-of-treatment opioid abusers transition to methadone maintenance treatment.
All study participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study conditions.
The experimental induction condition will receive low threshold stepped care (LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance treatment (i.e., one counseling session / month).
This condition will be compared to routine stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling schedules contingent on drug use or poor adherence.
RSC is routine treatment at ATS.
All participants will receive routine stepped care following the 3-month induction phase, and will have the opportunity to remain in treatment at ATS following study participation.
Participation is for 4-months.
Retention is the primary outcome.
Participants will also submit urine samples weekly on a random schedule each month.
We hypothesize that LTSC participants will exhibit better retention than RSC participants, and that both conditions will exhibit reductions in drug use compared to baseline.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Maryland
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Baltimore, Maryland, Forente stater, 21224
- Addiction Treatment Services -- Hopkins Bayview
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- New admissions to methadone maintenance
Exclusion Criteria:
- Pregnant
- Acute medical or psychiatric condition
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 3-month counseling induction: routine care
Participants assigned to this condition will receive routine stepped-care treatment at ATS. Participants will begin in Step 2 (one counseling session per week), and be advanced to higher intensity care based on missed counseling sessions and drug-positive urine samples.
Participants advanced to Step 3 will be scheduled to attend 2 group counseling sessions per week (in addition to individual counseling), and those advanced to Step 4 will be scheduled to attend 8 group counseling sessions per week (in addition to individual counseling).
Time of methadone dosing will be based on step of care.
|
Stepped-based care is routine treatment at ATS. Participants begin a low intensity care, and are advanced to more intensive levels of care (i.e., more intensive schedules of counseling) based on urine samples and counseling adherence.
|
|
Eksperimentell: 3-month counseling induction: low threshold
Participants assigned to this treatment arm will receive low threshold counseling.
These participants will be scheduled to attend one counseling session per month with their individual counselor for the first 3-months.
Participants can attend more counseling sessions if they desire, and they can meet with program supervisors to address crisis situations.
They can receive methadone dosing any time during the clinic hours (7:30 am-1:15 pm and 4:00 pm - 6:00 pm)
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Low threshold care refers to a service delivery method that reduces the treatment demands for new admissions to substance abuse treatment.
In the present study, participants will be scheduled to attend less counseling sessions, and will have greater access to methadone.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
treatment retention
Tidsramme: 120 days
|
The number of days patients remained in treatment over the 120 day study.
|
120 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Drug use
Tidsramme: weekly observation for 120 days
|
Urinalysis testing is administered weekly, using a random testing schedule.
Samples are tested for the presence of opioids, cocaine, and benzodiazepines
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weekly observation for 120 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael S Kidorf, Ph.D., Johns Hopkins University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2008
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
10. juni 2010
Først innsendt som oppfylte QC-kriteriene
10. juni 2010
Først lagt ut (Anslag)
11. juni 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- da012347-4
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