Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients - Full Text View

Sponsor:	Hospital Universitari Vall d'Hebron Research Institute
Information provided by:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT00495092

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 II Phase III

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:

MedlinePlus related topics: Anxiety Caffeine

Drug Information available for: Cocaine hydrochloride 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Biperiden Biperiden hydrochloride Biperiden lactate

U.S. FDA Resources

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 ]

Estimated Enrollment:	90
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2010
Estimated 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

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
Sub-Investigator: Roncero Carlos, MD
Sub-Investigator: Xavier Castells, MD
Sub-Investigator: Mavi Trasobares
Sub-Investigator: Margarita Corominas
Sub-Investigator: Marta Ribasés
Sub-Investigator: Sergi Valero

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:	May 26, 2010
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 February 09, 2012