Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00495183
First received: June 29, 2007
Last updated: May 26, 2010
Last verified: May 2010
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- cocaine use [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
| 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
Placebo+placebo
|
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495183
Contacts
| Contact: Miquel Casas, Prof. | 0034 93 489 42 94 | mcasas@vhebron.net |
| Contact: Xavier Castells, MD | 0034 93 489 42 94 | xcc@icf.uab.cat |
Locations
| Spain | |
| Hospital Universitari Vall d'Hebron | Recruiting |
| Barcelona, Catalonia, Spain, 08035 | |
| Contact: Miquel Casas, Prof 0034 93 489 42 94 mcasas@vhebron.net | |
| Contact: Xavier Castells, MD xcc@icf.uab.cat | |
| 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
Investigators
| Principal Investigator: | Miquel Casas, Prof. | Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain |
More Information
No publications provided
| Responsible Party: | Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron |
| ClinicalTrials.gov 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 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
cocaine dependence cocaine use CNS stimulants |
caffeine biperiden placebo |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Biperiden Caffeine Cocaine Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Central Nervous System Stimulants Phosphodiesterase Inhibitors Enzyme Inhibitors Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Vasoconstrictor Agents Cardiovascular Agents Dopamine Uptake Inhibitors Dopamine Agents |
ClinicalTrials.gov processed this record on June 18, 2013