Cocaine DependencePhase 4NCT00495183
Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
A Phase 4 study testing caffeine and Biperiden in people with Cocaine Dependence, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- caffeine and Biperiden
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
Miquel Casas, Prof, 0034 93 489 42 94, mcasas@vhebron.net
Xavier Castells, MD, xcc@icf.uab.cat
About this study
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.
- Conditions
- Cocaine Dependence
- Being tested
- caffeine, Biperiden, Placebo
- Keywords
- cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineDrug
Also called Durvitan
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
BiperidenDrug
Also called Akineton
Biperiden 2-4 mg/d, divided in 2 doses per day.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | caffeine + placebo Receives: Drug: caffeine |
| 2 | Experimental | caffeine + biperiden Receives: Drug: caffeine; Drug: Biperiden |
| 3 | Placebo comparator | Placebo+placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: 22 weeks
cocaine use
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJan 2009
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Miquel Casas, Prof., Principal investigator, Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495183
- Sponsor's protocol ID
- CAF-MT
- Other IDs
- eudraCT 2005-06-01
- Status last verified
- May 2010
- First submitted
- 29 Jun 2007
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00495183
- Acronym / sponsor ID
- CAF-MT
- Conditions
- Cocaine Dependence
- Keywords
- cocaine dependence, cocaine use, CNS stimulants, caffeine, biperiden, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: caffeinecaffeine + placebo |
| 2 | Experimental | Drug: caffeine, Drug: Biperidencaffeine + biperiden |
| 3 | Placebo comparator | Drug: PlaceboPlacebo+placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeineAlso: Durvitancaffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day. | Drug | 1, 2 |
| BiperidenAlso: AkinetonBiperiden 2-4 mg/d, divided in 2 doses per day. | Drug | 2 |
| PlaceboPlacebo | Drug | 3 |
Primary outcome
survival
Time frame: 22 weeks
cocaine use
Time frame: 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Casas, Prof. principal investigator
Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing caffeine and Biperiden in people with Cocaine Dependence, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miquel Casas, Prof. (0034 93 489 42 94, mcasas@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 22 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.