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

NCT00495092 | Completed Phase 2 DMC

• 2 other identifiers: CAF-DTX-1INT/71525/2003
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Related Disorders

Keywords

cocaine dependence; cocaine use; cocaine craving

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

1

EXPERIMENTAL

This study arm will receive caffeine+placebo

Drug: Caffeine

2

EXPERIMENTAL

this study arm will receive Caffeine+Biperiden

Drug: Caffeine; Drug: Biperiden

3

PLACEBO COMPARATOR

this study arm will receive placebo+placebo

Drug: Placebo

Interventions

Caffeine DRUG

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

1; 2

Biperiden DRUG

Biperiden 2-4 mg/d p.o.

2

Placebo DRUG

Placebo + Placebo

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Caffeine; Biperiden

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Miquel Casas, Prof.

  Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2010
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

ES (1)