NCT00495183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

1.5 years

First QC Date

June 29, 2007

Last Update Submit

May 26, 2010

Conditions

Cocaine Dependence

Keywords

cocaine dependencecocaine useCNS stimulantscaffeinebiperidenplacebo

Outcome Measures

Primary Outcomes (2)

  • survival

    22 weeks

  • cocaine use

    22 weeks

Study Arms (3)

1

EXPERIMENTAL

caffeine + placebo

Drug: caffeine

2

EXPERIMENTAL

caffeine + biperiden

Drug: caffeineDrug: Biperiden

3

PLACEBO COMPARATOR

Placebo+placebo

Drug: Placebo

Interventions

caffeineDRUG

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

Also known as: Durvitan
12
BiperidenDRUG

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

Also known as: Akineton
2
PlaceboDRUG

Placebo

3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

CaffeineBiperiden

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingAzabicyclo CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Miquel Casas, Prof.

    Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Casas, Prof.

CONTACT

0034 93 489 42 94mcasas@vhebron.net

Xavier Castells, MD

CONTACT

0034 93 489 42 94xcc@icf.uab.cat

Study Design

Study Type
interventional
Phase
phase 4
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, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

ES(1)