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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

caffeine + placebo

Group Type EXPERIMENTAL

caffeine

Intervention Type DRUG

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

2

caffeine + biperiden

Group Type EXPERIMENTAL

caffeine

Intervention Type DRUG

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

Biperiden

Intervention Type DRUG

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

3

Placebo+placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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caffeine

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

Intervention Type DRUG

Biperiden

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Durvitan Akineton

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No