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Effectiveness of Bupropion Combined With Behavioral Therapy for Treating Methamphetamine Dependence - 2

11. januar 2017 opdateret af: National Institute on Drug Abuse (NIDA)

A Randomized, Double-Blind, Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence

Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the brain. The purpose of this study is to determine the effectiveness of bupropion in combination with behavioral therapy for the treatment of methamphetamine addiction.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and norepinephrine to be released into the brain. This overload produces unusual alertness and feelings of elation. When the body undergoes methamphetamine withdrawal, it experiences a reduction in dopamine and norepinephrine. Bupropion is an antidepressant used for the treatment of depression and smoking cessation. Because it functions by increasing the release of dopamine and norepinephrine in the brain, bupropion is likely to decrease the negative effects of methamphetamine withdrawal. The purpose of this study is to evaluate the efficacy of bupropion combined with contingency management (CM) and cognitive behavioral counseling (CBT) as a means of treating methamphetamine dependence.

An initial 2-week screening process will involve participants providing urine samples and completing physical and psychological assessments. If deemed eligible for the remainder of this double-blind study, participants will be randomly assigned to receive either bupropion or placebo over the course of 12 weeks. Participants in both the bupropion and placebo groups will receive contingency management and cognitive behavioral counseling. Participants will report to one of two clinical research sites three times per week. At each visit, participants will be examined by the study staff, provide a urine sample, and receive individual cognitive behavioral counseling sessions. At the end of 12 weeks, treatment will be stopped. Participants will return to the study site 30 days later for evaluation and to be assessed for any possible lingering side effects.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

73

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

    • California
      • Los Angeles, California, Forenede Stater, 90024
        • UCLA Medical Center
      • Rancho Cucamonga, California, Forenede Stater, 91730
        • Rancho Cucamonga 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

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Meets DSM-IV criteria for methamphetamine dependence
  • Females must use an effective method of contraception

Exclusion Criteria:

  • History of or current medical condition that might interfere with safe participation, such as active tuberculosis, unstable heart or liver disease, unstable diabetes, symptomatic AIDS (non-symptomatic HIV infection is not an exclusion), or greater than 8 times the upper limit of normal in liver screening function tests (SGOT or SGPT)
  • Current neurological disorder (e.g., organic brain disease, dementia)
  • Major psychiatric disorder unrelated to substance abuse, such as schizophrenia or bipolar disorder (assessed by the SCID and a medical history)
  • Suicide attempt within the month prior to enrollment and/or currently suicidal (assessed by the SCID and the BDI II)
  • Currently on prescription medication that might interact with the study drug
  • Currently dependent on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria
  • History of alcohol dependence within past three years
  • History of seizure disorders
  • History of anorexia or bulimia
  • Current hypertension uncontrolled by medication
  • History of sensitivity to bupropion
  • Pregnant or breastfeeding

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
Placebo komparator: 2
Placebo
Aktiv komparator: 1
Bupropion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Addiction severity, Week 16
Drug use, Week 16

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Steve Shoptaw, Ph.D., University of California, Los Angeles

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. oktober 2005

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

23. august 2005

Først indsendt, der opfyldte QC-kriterier

23. august 2005

Først opslået (Skøn)

26. august 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2017

Sidst verificeret

1. september 2009

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 Placebo

3
Abonner