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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: July 2010
- Drug: caffeine
- caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
- Drug: Biperiden
- Biperiden 2-4 mg/d, divided in 2 doses per day.
- Drug: Placebo
Arms, Groups and Cohorts
- Experimental: 1
- caffeine + placebo
- Experimental: 2
- caffeine + biperiden
- Placebo Comparator: 3
Clinical Trial Outcome Measures
- Time Frame: 22 weeks
- cocaine use
- Time Frame: 22 weeks
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Hospital Universitari Vall d’Hebron Research Institute
- Provider of Information About this Clinical Study
- Miguel Casas Brugué, Servei de Psiquiatria. Hospital Universitari Vall d’Hebron
- Overall Official(s)
- Miquel Casas, Prof., Principal Investigator, Hospital Universitari Vall d’Hebron Barcelona, Catalonia, Spain
- Overall Contact(s)
- Miquel Casas, Prof., 0034 93 489 42 94, email@example.com
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