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

Cocaine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00495183
• Other study ID #: CAF-MT
• Secondary ID: eudraCT 2005-06-
• Status: Recruiting
• Phase: Phase 4
• First received: June 29, 2007
• Last updated: May 26, 2010
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Miquel Casas, Prof.
• Phone: 0034 93 489 42 94
• Email: mcasas[@]vhebron.net
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
• Biperiden
Biperiden 2-4 mg/d, divided in 2 doses per day.
• Placebo
Placebo

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival		22 weeks	No
Primary	cocaine use		22 weeks	No