Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

Overview

The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied. 108 with cocaine dependence will be randomized to receive caffeine (300 – 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 – 1200 mg t.i.d.) with placebo or placebo during 6 months. Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use. Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.

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: December 2009

Interventions

  • Drug: Caffeine
    • Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
  • Drug: Biperiden
    • Biperiden 2-4 mg/d p.o.
  • Drug: Placebo
    • Placebo + Placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • This study arm will receive caffeine+placebo
  • Experimental: 2
    • this study arm will receive Caffeine+Biperiden
  • Placebo Comparator: 3
    • this study arm will receive placebo+placebo

Clinical Trial Outcome Measures

Primary Measures

  • 1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
    • Time Frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosis of intranasal 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 centre. – 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, iodine or apomorphine 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

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