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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00495183

Enrollment

108

Registered

2007-07-02

Start date

2009-01-31

Completion date

2010-07-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence

Keywords

cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo

Brief 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.

Interventions

DRUGcaffeine

caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.

DRUGBiperiden

Biperiden 2-4 mg/d, divided in 2 doses per day.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
survival	22 weeks
cocaine use	22 weeks

Countries

Spain

Contacts

Primary ContactMiquel Casas, Prof.

mcasas@vhebron.net0034 93 489 42 94

Backup ContactXavier Castells, MD

xcc@icf.uab.cat0034 93 489 42 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026