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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute Identifier:
First received: June 29, 2007
Last updated: May 26, 2010
Last verified: May 2010

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.

Condition Intervention Phase
Cocaine Dependence
Drug: caffeine
Drug: Biperiden
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence

Resource links provided by NLM:

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • survival [ Time Frame: 22 weeks ]
  • cocaine use [ Time Frame: 22 weeks ]

Estimated Enrollment: 108
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
caffeine + placebo
Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
Other Name: Durvitan
Experimental: 2
caffeine + biperiden
Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
Other Name: Durvitan
Drug: Biperiden
Biperiden 2-4 mg/d, divided in 2 doses per day.
Other Name: Akineton
Placebo Comparator: 3
Drug: Placebo


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00495183

Contact: Miquel Casas, Prof. 0034 93 489 42 94
Contact: Xavier Castells, MD 0034 93 489 42 94

Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Catalonia, Spain, 08035
Contact: Miquel Casas, Prof    0034 93 489 42 94   
Contact: Xavier Castells, MD   
Sub-Investigator: Carlos Roncero, MD         
Sub-Investigator: Castells Xavier, MD         
Sub-Investigator: Gonzalvo Begoña, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Principal Investigator: Miquel Casas, Prof. Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
  More Information

Responsible Party: Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron Identifier: NCT00495183     History of Changes
Other Study ID Numbers: CAF-MT
eudraCT 2005-06-01
Study First Received: June 29, 2007
Last Updated: May 26, 2010

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
cocaine dependence
cocaine use
CNS stimulants

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Biperiden lactate
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Central Nervous System Stimulants
Phosphodiesterase Inhibitors processed this record on May 22, 2017