Cocaine Related DisordersPhase 2/3NCT00495092
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
A Phase 2/3 study testing Caffeine and Biperiden in people with Cocaine Related Disorders, 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 in detoxifying cocaine dependent patients. 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 Related Disorders
- What is being tested?
- Caffeine and Biperiden
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2005to Oct 2010
- Phase
- Phase 2/3
- 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 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.
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, 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.
Show all 9Show fewer
- 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.
About this study
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
- Being tested
- Caffeine, Biperiden, Placebo
- Keywords
- cocaine dependence, cocaine use, cocaine craving
- 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
Caffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d
BiperidenDrug
Biperiden 2-4 mg/d p.o.
PlaceboDrug
Placebo + Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This study arm will receive caffeine+placebo Receives: Drug: Caffeine |
| 2 | Experimental | this study arm will receive Caffeine+Biperiden Receives: Drug: Caffeine; Drug: Biperiden |
| 3 | Placebo comparator | this study arm will receive placebo+placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
Measured: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.
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 2005
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Related DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
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
- NCT00495092
- Sponsor's protocol ID
- CAF-DTX-1
- Other IDs
- INT/71525/2003
- Status last verified
- Feb 2012
- First submitted
- 29 Jun 2007
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
- ClinicalTrials.gov ID
- NCT00495092
- Acronym / sponsor ID
- CAF-DTX-1
- Conditions
- Cocaine Related Disorders
- Keywords
- cocaine dependence, cocaine use, cocaine craving
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- 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 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.
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: CaffeineThis study arm will receive caffeine+placebo |
| 2 | Experimental | Drug: Caffeine, Drug: Biperidenthis study arm will receive Caffeine+Biperiden |
| 3 | Placebo comparator | Drug: Placebothis study arm will receive placebo+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 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.
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, 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
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 |
|---|---|---|
| CaffeineCaffeine from 300 mg/d to 1200 mg/d or 15 mg/kg/d | Drug | 1, 2 |
| BiperidenBiperiden 2-4 mg/d p.o. | Drug | 2 |
| PlaceboPlacebo + Placebo | Drug | 3 |
Primary outcome
1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
Time frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
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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 2/3 study testing Caffeine and Biperiden in people with Cocaine Related Disorders, 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: finished, as of the sponsor's last update on 1 Mar 2012. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use. (time frame: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.). 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 1 Mar 2012.