Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Information source: Hospital Universitari Vall d'Hebron Research Institute
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Related Disorders
Intervention: Caffeine (Drug); Biperiden (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Hospital Universitari Vall d'Hebron Research Institute Official(s) and/or principal investigator(s):
Miquel Casas, Prof., Principal Investigator, Affiliation: Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
Overall contact:
Miquel Casas, Prof., Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net
Summary
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.
Clinical Details
Official title: Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Miquel Casas, Prof., Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net
Hospital Universitari Vall d'Hebron, Barcelona, Catalonia 08035, Spain; Recruiting
Miquel Casas, Prof, Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net
Roncero Carlos, MD, Sub-Investigator
Xavier Castells, MD, Sub-Investigator
Mavi Trasobares, Sub-Investigator
Margarita Corominas, Sub-Investigator
Marta Ribasés, Sub-Investigator
Sergi Valero, Sub-Investigator
Additional Information
Starting date: January 2005
Last updated: May 26, 2010
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