Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence

Overview

The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied. Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 – 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 – 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: caffeine
    • caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
  • Drug: Biperiden
    • Biperiden 2-4 mg/d, divided in 2 doses per day.
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • caffeine + placebo
  • Experimental: 2
    • caffeine + biperiden
  • Placebo Comparator: 3
    • Placebo+placebo

Clinical Trial Outcome Measures

Primary Measures

  • survival
    • Time Frame: 22 weeks
  • cocaine use
    • Time Frame: 22 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosis of cocaine dependence, according to DSM-IV-TR criteria – age between 18 and 60 years – current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission. – demonstrated capacity to grant informed consent and sign the pertinent informed consent form. – place of residence compatible with attendance at the center. – for women, willingness to use effective contraceptive measures during the study. Exclusion Criteria:

  • diagnosis of a severe medical disorder that could interfere with the study – presence of an organic pathology for which methylxanthines or biperidene administration is contraindicated – serum liver transaminase levels 3 times higher than normal values – pregnancy and breast-feeding – neuroleptic medication treatment in the past 6 weeks – current treatment, or anticipation that the patient may need to initiate treatment during the study, with drugs that may interact with study medication. – current diagnosis of a major mental disorder. – awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence) – current participation in another research project.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Miguel Casas BruguĂ©, Servei de Psiquiatria. Hospital Universitari Vall d’Hebron
  • Overall Official(s)
    • Miquel Casas, Prof., Principal Investigator, Hospital Universitari Vall d’Hebron Barcelona, Catalonia, Spain
  • Overall Contact(s)
    • Miquel Casas, Prof., 0034 93 489 42 94, mcasas@vhebron.net

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