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

Study Overview
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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.

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

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: caffeine
* Drug: Biperiden
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>caffeine + placebo | Drug: caffeine<br>* caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.<br>* Other names: Durvitan;|
| Experimental: 2<br>caffeine + biperiden | Drug: caffeine<br>* caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.<br>* Other names: Durvitan;Drug: Biperiden<br>* Biperiden 2-4 mg/d, divided in 2 doses per day.<br>* Other names: Akineton;|
| Placebo Comparator: 3<br>Placebo+placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 22 weeks | 
| cocaine use |  | 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo