Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence (NCT00495183) | Clinical Trial Compass
UnknownPhase 4
Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
Spain108 participantsStarted 2009-01
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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.
What they're measuring
1
survival
Timeframe: 22 weeks
2
cocaine use
Timeframe: 22 weeks
Trial details
NCT IDNCT00495183
SponsorHospital Universitari Vall d'Hebron Research Institute