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

NCT ID: NCT00495092

Last Updated: 2012-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-10-31

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.

Conditions

Cocaine Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

This study arm will receive caffeine+placebo

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DRUG

Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d

2

this study arm will receive Caffeine+Biperiden

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DRUG

Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d

Biperiden

Intervention Type: DRUG

Biperiden 2-4 mg/d p.o.

3

this study arm will receive placebo+placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo + Placebo

Interventions

Caffeine

Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d

Intervention Type: DRUG

Biperiden

Biperiden 2-4 mg/d p.o.

Intervention Type: DRUG

Placebo

Placebo + Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Servei de Psiquiatria. Hospital Universitari Vall d'Hebron

Principal Investigators

Miquel Casas, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Locations

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Countries

Spain

Other Identifiers

INT/71525/2003

Identifier Type: -

Identifier Source: secondary_id

CAF-DTX-1

Identifier Type: -

Identifier Source: org_study_id