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

Primary Purpose

Cocaine Dependence

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

caffeine

Biperiden

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

caffeine + placebo

caffeine + biperiden

Placebo+placebo

Outcomes

Primary Outcome Measures

survival

cocaine use

Secondary Outcome Measures

Full Information

NCT ID

NCT00495183

First Posted

June 29, 2007

Last Updated

May 26, 2010

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00495183

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

July 2010 (Anticipated)

Study Completion Date

July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

Keywords

cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

caffeine + placebo

Arm Title

Arm Type

Experimental

Arm Description

caffeine + biperiden

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo+placebo

Intervention Type

Drug

Intervention Name(s)

caffeine

Other Intervention Name(s)

Durvitan

Intervention Description

caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.

Intervention Type

Drug

Intervention Name(s)

Biperiden

Other Intervention Name(s)

Akineton

Intervention Description

Biperiden 2-4 mg/d, divided in 2 doses per day.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

survival

Time Frame

22 weeks

Title

cocaine use

Time Frame

22 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miquel Casas, Prof.

Phone

0034 93 489 42 94

mcasas@vhebron.net

First Name & Middle Initial & Last Name or Official Title & Degree

Xavier Castells, MD

Phone

0034 93 489 42 94

xcc@icf.uab.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miquel Casas, Prof.

Organizational Affiliation

Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

State/Province

Catalonia

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miquel Casas, Prof

Phone

0034 93 489 42 94

mcasas@vhebron.net

First Name & Middle Initial & Last Name & Degree

Xavier Castells, MD

xcc@icf.uab.cat

First Name & Middle Initial & Last Name & Degree

Carlos Roncero, MD

First Name & Middle Initial & Last Name & Degree

Castells Xavier, MD

First Name & Middle Initial & Last Name & Degree

Gonzalvo Begoña, MD

12. IPD Sharing Statement

Learn more about this trial

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

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