- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01526538
Improving Learning-based Treatment of Cocaine Dependence With Medication
22. december 2016 opdateret af: Matthew Johnson, Johns Hopkins University
This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Cocaine dependence is a public health problem with substantial morbidity, however no effective pharmacotherapy for cocaine dependence has been approved by the FDA.
Unlike previous medication studies that have sought to pharmacologically reduce cocaine reinforcement, seeking or craving, this exploratory clinical trial will test d-cycloserine (DCS) for its ability to improve learning-based behavioral treatment of cocaine dependence.
DCS is an NMDA partial agonist that has been shown to robustly improve learning in preclinical models, including extinction of cocaine conditioned place preference and blockade of cocaine reacquisition, and to improve extinction-learning based exposure therapy for multiple anxiety disorders.
This Phase II clinical trial will investigate the pharmacological (DCS) enhancement of a behavioral treatment combining contingency management (CM) and novel home-environment exposure therapy sessions for cocaine dependence.
High magnitude CM incentives will be used to promote the cocaine abstinence necessary for extinction in home-based exposure sessions.
Participants will be randomized into 2 groups: 1. CM with placebo (CM+PL), and 2. CM with DCS (CM+DCS).
For 19 days after group assignment, participants will report to the laboratory 3 times per week (Mon, Wed, Fri) to provide urine samples, receive contingent vouchers, and complete assessments of drug use, craving, mood, withdrawal, and quit self-efficacy.
DCS (50 mg) or placebo will be administered on Mon, Wed and Fri study visits (at the end of the lab visit before returning to the home environment for exposure sessions during the time of DCS action).
Follow-up visits will be conducted at 1 week, 1 month, and 3 months post-CM completion, during which time measures of drug use (self-reported and urinalysis), craving, mood, and withdrawal will be obtained.
Comparison of continuous abstinence post-CM between the groups will be the primary outcome measure.
During an initial laboratory session, a battery of learning/cognitive tasks will test for forms of learning/cognition enhanced by DCS that might contribute to the treatment effect.
This project will test the efficacy of a novel intervention for cocaine dependence that was developed based on a known efficacious cocaine dependence treatment (CM), principles of extinction learning theory, and a medication shown to improve preclinical learning in general, including extinction of cocaine conditioning, and clinical learning-based exposure treatment of anxiety disorders.
The study may indicate cost effective additions (home exposure sessions and DCS) to extend CM benefit after the removal of contingencies, and therefore may increase the dissemination of CM in community settings.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
52
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 212124
- Behavioral Pharmacology Research Unit
-
-
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 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18-60 years of age (> 60 due to age-related effects on cognitive functioning)
- Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
- Able to complete all study measures
- Currently seeking treatment for cocaine dependence
Exclusion Criteria:
- Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
- Pregnant, breast feeding, or planning to become pregnant within 3 months
- If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
- History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
- Diagnosis of current major psychiatric disorder besides substance dependence or abuse
- Reported use of DCS in the past year
- Illiteracy, as will be determined during in-person screening
- Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
- Positive urine result for opioids at screening interview
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 50 mg d-cycloserine
active drug condition
|
50 mg d-cycloserine
|
Placebo komparator: Sugar pill
Inactive placebo
|
placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)
Tidsramme: 1 month post-treatment
|
The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results
|
1 month post-treatment
|
Medication Side-effects
Tidsramme: 1 month post-treatment.
|
self-report of medication side effects (Units of Measure is the count of specific reported effects)
|
1 month post-treatment.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Learning Task by Itami and Uno
Tidsramme: At the baseline laboratory visit
|
At the baseline laboratory visit
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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. september 2011
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
30. januar 2012
Først indsendt, der opfyldte QC-kriterier
3. februar 2012
Først opslået (Skøn)
6. februar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Kokain-relaterede lidelser
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antimetabolitter
- Antibakterielle midler
- Antituberkulære midler
- Antibiotika, Antituberkulær
- Anti-infektionsmidler, urinveje
- Nyremidler
- Cycloserin
Andre undersøgelses-id-numre
- R21DA029823 (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 .
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