Overview

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

Status:
Unknown status
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Treatments:
Biperiden
Biperiden lactate
Caffeine
Cocaine
Criteria
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.