Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
This study has been completed.
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Related Disorders |
Drug: Caffeine Drug: Biperiden Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients |
Resource links provided by NLM:
Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:
Primary Outcome 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. ] [ Designated as safety issue: No ]
| Enrollment: | 85 |
| Study Start Date: | January 2005 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
This study arm will receive caffeine+placebo
|
Drug: Caffeine
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
|
|
Experimental: 2
this study arm will receive Caffeine+Biperiden
|
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.
|
|
Placebo Comparator: 3
this study arm will receive placebo+placebo
|
Drug: Placebo
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495092
Locations
| Spain | |
| Hospital Universitari Vall d'Hebron | |
| Barcelona, Catalonia, Spain, 08035 | |
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: | NCT00495092 History of Changes |
| Other Study ID Numbers: | CAF-DTX-1, INT/71525/2003 |
| Study First Received: | June 29, 2007 |
| Last Updated: | February 29, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
cocaine dependence cocaine use cocaine craving |
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