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

Cocaine Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495092
• Other study ID #: CAF-DTX-1
• Secondary ID: INT/71525/2003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 29, 2007
• Last updated: February 29, 2012
• Start date: January 2005
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Related Disorders
• Cocaine-Related Disorders

Intervention

Drug:
• Caffeine
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
• Biperiden
Biperiden 2-4 mg/d p.o.
• Placebo
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	1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.		12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.	No