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

Condition(s) targeted: Cocaine Dependence

Intervention: caffeine (Drug); Biperiden (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Universitari Vall d'Hebron Research Institute

Official(s) and/or principal investigator(s):
Miquel Casas, Prof., Principal Investigator, Affiliation: Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

Overall contact:
Miquel Casas, Prof., Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

survival

cocaine use

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Miquel Casas, Prof., Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net

Hospital Universitari Vall d'Hebron, Barcelona, Catalonia 08035, Spain; Recruiting
Miquel Casas, Prof, Phone: 0034 93 489 42 94, Email: mcasas@vhebron.net
Xavier Castells, MD, Email: xcc@icf.uab.cat
Carlos Roncero, MD, Sub-Investigator
Castells Xavier, MD, Sub-Investigator
Gonzalvo Begoña, MD, Sub-Investigator

Starting date: January 2009
Ending date: July 2010
Last updated: April 28, 2009