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

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.

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Key information

Conditions

Cocaine Related Disorders Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine

Drug

Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d

Biperiden

Drug

Biperiden 2-4 mg/d p.o.

Placebo

Drug

Placebo + Placebo

Primary outcomes

1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.

Time frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2010
First posted: Jul 2, 2007
Registry last updated: Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed