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

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 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.

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

Conditions
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Cocaine Related Disorders

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 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.

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>This study arm will receive caffeine+placebo | Drug: Caffeine<br>* Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d<br>|
| Experimental: 2<br>this study arm will receive Caffeine+Biperiden | Drug: Caffeine<br>* Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d<br>Drug: Biperiden<br>* Biperiden 2-4 mg/d p.o.<br>|
| Placebo Comparator: 3<br>this study arm will receive placebo+placebo | Drug: Placebo<br>* Placebo + Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use. |  | 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence, cocaine use, cocaine craving