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

This study is currently recruiting participants.

Verified May 2010 by Hospital Universitari Vall d'Hebron Research Institute

First Received on June 29, 2007. Last Updated on May 26, 2010 History of Changes

Sponsor:	Hospital Universitari Vall d'Hebron Research Institute
Information provided by:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT00495183

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 IV

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:

MedlinePlus related topics: 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:

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 February 09, 2012