search
Back to results

Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

Primary Purpose

Cocaine Related Disorders

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Caffeine
Biperiden
Placebo
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Related Disorders focused on measuring cocaine dependence, cocaine use, cocaine craving

Eligibility Criteria

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

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.

Sites / Locations

  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

This study arm will receive caffeine+placebo

this study arm will receive Caffeine+Biperiden

this study arm will receive placebo+placebo

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2007
Last Updated
February 29, 2012
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00495092
Brief Title
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Official Title
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2010 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Related Disorders
Keywords
cocaine dependence, cocaine use, cocaine craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
This study arm will receive caffeine+placebo
Arm Title
2
Arm Type
Experimental
Arm Description
this study arm will receive Caffeine+Biperiden
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
this study arm will receive placebo+placebo
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
Intervention Type
Drug
Intervention Name(s)
Biperiden
Intervention Description
Biperiden 2-4 mg/d p.o.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo + Placebo
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

We'll reach out to this number within 24 hrs