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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


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
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