Cocaine AddictionPhase 3CAIMANNCT00701532
Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction
A Phase 3 study testing Modafinil and PET (brain imaging) in people with Cocaine Addiction and Cocaine Dependence, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Cocaine Addiction, Cocaine Dependence
- What is being tested?
- Modafinil and PET (brain imaging)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2009to Jan 2013
- Phase
- Phase 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men of at least 18 years of age
- Cocaine dependent according to DSM IV TR criteria
- Seeking treatment
- Capable of understanding and giving their informed written consent
- With National Health coverage
- Urinary screen positive for cocaine in the weeks prior to inclusion
Who cannot join
- Women
- Other DSM IV TR axe I diagnostic criteria (except for tobacco)
- Neurological disorders
- Treatment that interferes with the DAT and modafinil
- Contraindications for modafinil and Magnetic Resonance Imaging
Trial locations and contacts
2 sites in 1 country.
France2 sites
Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot
Orsay, 91401
Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse
Villejuif, 94800
About this study
Official title: Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.
Read the detailed description
Context:
Cocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminergic system dysregulation plays a fundamental role in reinforcement phenomenon and in dependence. This has been proven in numerous animal and post-death human studies of striatal DAT. In vivo studies in cocaine dependent patients are rare. Currently no pharmacotherapy is available to treat this pathology. Current studies indicate that pharmacological agents such as modafinil may be able to reverse the neuroadaptations induced by cocaine dependence. However, no functional neuroimaging study (Positron Emission Tomography, PET) has analysed the impact of medications on DAT density in cocaine dependent patients. However, in primates, in vivo PET has shown modafinil affinity for DAT.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during therapeutic cocaine withdrawal.
Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
Secondary:
Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.
Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.
Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.
Calculation of the number of subjects: A power of 90% is found for a number of subjects estimated at 24 (bilateral test, α risk at 5%, estimated SEM of 5%, variation of the occupational concentration of the DAT expected to be at least 12% in the modafinil group). Considering the usual rate of patients lost to follow-up in this patient population (25%), we plan to include 30 patients.
Methodology: This study is regulated by the law on biomedical research of August 9, 2004. It is a randomised monocentric double blind study versus placebo. During the study, for 90 days, patients will receive in double blind either modafinil or placebo according to their randomisation arm.
Evaluations will include 2 PET, cerebral MRI, blood work-up, urinary toxin screen, clinical scales for craving, depression and neuropsychological evaluations.
Patients will be recruited over 24 months. The total study length will be 36 months.
Primary judgment criteria: Variation of the linking potentials (specific fixation rate for the radioligand [11C]-PE2I to DAT) between the TEP measurement on D3 and D21 within the various anatomical region of interest between the 2 groups (modafinil, placebo).
Expected Results: Decreased DAT occupation rates in the modafinil group versus placebo from D3 to D21 of withdrawal.
- Conditions
- Cocaine Addiction, Cocaine Dependence
- Being tested
- Modafinil and PET (brain imaging), placebo
- Keywords
- Cocaine, Substance abuse, Addiction, Dependence, Modafinil, Brain imaging
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modafinil and PET (brain imaging)Drug
duration 90 days
placeboDrug
duration 90 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | active Receives: Drug: Modafinil and PET (brain imaging) |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.
Measured: day 3 and day of cocaine detoxification
Secondary outcomes (4)
Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.
Measured: D3 to D90
Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.
Measured: D3 to D21
Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.
Measured: D3 to D21
Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.
Measured: D3 to D90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startApr 2009
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
- Responsible party
- Sponsor
- Investigators
- Michel Reynaud, PhD, Study director, Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701532
- Sponsor's protocol ID
- P070150
- Acronym
- CAIMAN
- Status last verified
- Apr 2013
- First submitted
- 18 Jun 2008
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study
- ClinicalTrials.gov ID
- NCT00701532
- Acronym / sponsor ID
- CAIMAN / P070150
- Conditions
- Cocaine Addiction, Cocaine Dependence
- Keywords
- Cocaine, Substance abuse, Addiction, Dependence, Modafinil, Brain imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
- Study start
- Apr 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Jun 2008 (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.
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.
Detailed description
Context:
Cocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminergic system dysregulation plays a fundamental role in reinforcement phenomenon and in dependence. This has been proven in numerous animal and post-death human studies of striatal DAT. In vivo studies in cocaine dependent patients are rare. Currently no pharmacotherapy is available to treat this pathology. Current studies indicate that pharmacological agents such as modafinil may be able to reverse the neuroadaptations induced by cocaine dependence. However, no functional neuroimaging study (Positron Emission Tomography, PET) has analysed the impact of medications on DAT density in cocaine dependent patients. However, in primates, in vivo PET has shown modafinil affinity for DAT.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during therapeutic cocaine withdrawal.
Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
Secondary:
Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.
Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.
Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.
Calculation of the number of subjects: A power of 90% is found for a number of subjects estimated at 24 (bilateral test, α risk at 5%, estimated SEM of 5%, variation of the occupational concentration of the DAT expected to be at least 12% in the modafinil group). Considering the usual rate of patients lost to follow-up in this patient population (25%), we plan to include 30 patients.
Methodology: This study is regulated by the law on biomedical research of August 9, 2004. It is a randomised monocentric double blind study versus placebo. During the study, for 90 days, patients will receive in double blind either modafinil or placebo according to their randomisation arm.
Evaluations will include 2 PET, cerebral MRI, blood work-up, urinary toxin screen, clinical scales for craving, depression and neuropsychological evaluations.
Patients will be recruited over 24 months. The total study length will be 36 months.
Primary judgment criteria: Variation of the linking potentials (specific fixation rate for the radioligand [11C]-PE2I to DAT) between the TEP measurement on D3 and D21 within the various anatomical region of interest between the 2 groups (modafinil, placebo).
Expected Results: Decreased DAT occupation rates in the modafinil group versus placebo from D3 to D21 of withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Modafinil and PET (brain imaging)active |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men of at least 18 years of age
- Cocaine dependent according to DSM IV TR criteria
- Seeking treatment
- Capable of understanding and giving their informed written consent
- With National Health coverage
Key exclusion criteria (5 listed)
- Women
- Other DSM IV TR axe I diagnostic criteria (except for tobacco)
- Neurological disorders
- Treatment that interferes with the DAT and modafinil
- Contraindications for modafinil and Magnetic Resonance Imaging
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 |
|---|---|---|
| Modafinil and PET (brain imaging)duration 90 days | Drug | 1 |
| placeboduration 90 days | Drug | 2 |
Primary outcome
Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.
Time frame: day 3 and day of cocaine detoxification
4 secondary outcomes
Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.
Time frame: D3 to D90
Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.
Time frame: D3 to D21
Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.
Time frame: D3 to D21
Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.
Time frame: D3 to D90
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 11 Apr 2013.
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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.
Michel Reynaud, PhD study director
Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil and PET (brain imaging) in people with Cocaine Addiction and Cocaine Dependence, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 5 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 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?
Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification. (time frame: day 3 and day of cocaine detoxification). 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 11 Apr 2013.