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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00495092
First received: June 29, 2007
Last updated: February 29, 2012
Last verified: February 2012
History of Changes

June 29, 2007
February 29, 2012
January 2005
December 2009   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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. ]
Complete list of historical versions of study NCT00495092 on ClinicalTrials.gov Archive Site
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Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Related Disorders
  • 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
  • Experimental: 1
    This study arm will receive caffeine+placebo
    Intervention: Drug: Caffeine
  • Experimental: 2
    this study arm will receive Caffeine+Biperiden
    Interventions:
    • Drug: Caffeine
    • Drug: Biperiden
  • Placebo Comparator: 3
    this study arm will receive placebo+placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
October 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00495092
CAF-DTX-1, INT/71525/2003
Yes
Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Miquel Casas, Prof. Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
Hospital Universitari Vall d'Hebron Research Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP