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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Unknown; Phase 4

Conditions: Cocaine Dependence

Treatments: Drug: Biperiden; Drug: caffeine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00495183

eudraCT 2005-06-01

CAF-MT

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

caffeine + placebo

Treatment:

Drug: caffeine

2

Experimental group

Description:

caffeine + biperiden

Treatment:

Drug: caffeine

Drug: Biperiden

3

Placebo Comparator group

Description:

Placebo+placebo

Treatment:

Drug: Placebo