Cocaine-Related DisordersNCT01984177
Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence
An observational study of Cocaine-Related Disorders and Cocaine Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study will, in a sample of cocaine-dependent and healthy control subjects, administer corticorelin and compare dopamine release between groups. Dopamine release will be measured using PET neuroimaging with the radiotracer [11C]-(+)-PHNO. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders, Cocaine Addiction, Substance-Related Disorders
- What is being tested?
- Corticotropin-Releasing Hormone
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jun 2016
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: CD subjects are recruited from the local community using flyers and internet advertisements, and through referral from local clinical programs. CD subjects are recruited from the community using flyers and internet advertisements.
Who may be able to join
- Sign and date informed consent
- Willing and able to complete trial as described in the protocol
- Psychiatrically healthy (as per diagnostic interview) except for cocaine dependence in cocaine users and nicotine dependence in both groups
- Mentally healthy
- Medically healthy (as per medical exam) with no current use of medications that may interfere with hormone activity or psychological measurements
Who cannot join
- Axis I psychiatric disorder (as per diagnostic interview), or medical condition that might interfere with participation in the study (as per medical exam)
- Exposure to radiation in the last 12 months exceeding the amount permissible by the CAMH PET centre
- Have received synthetic glucocorticoid or exogenous steroid therapy within one month of testing
- Exceed normal body weight
- If female: pregnancy or breast-feeding
- Metal implants or paramagnetic objects contained within the body
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence: A [11C]-(+)-PHNO PET Investigation
This study will, in a sample of cocaine-dependent and healthy control subjects, administer corticorelin and compare dopamine release between groups. Dopamine release will be measured using PET neuroimaging with the radiotracer [11C]-(+)-PHNO.
Read the detailed description
SCIENTIFIC SUMMARY The project will, in a sample of cocaine-dependent (CD) and healthy control (HC) subjects, use administration of Corticorelin, a synthetic form of corticotropin releasing factor (CRF)and PET imaging to assess dopamine (DA) transmission in addiction. We will use [11C]-(+)-PHNO PET to measure striatal DA receptor binding on two occasions: 1) following corticorelin administration and 2) following saline. The change in receptor binding between the two occasions (i.e., displacement of [11C]-(+)-PHNO by endogenous DA) will index DA release.
SUBJECTS CD subjects will meet DSM-IV criteria for abuse or dependence and be ~10d cocaine abstinent at the time of PET. HC will be recruited to match CD on age, sex, education, and cigarette smoking.
PRIMARY OUTCOME MEASURES We will measure [11C]-(+)-PHNO binding on two occasions (corticorelin, saline), with the difference between conditions indexing dopamine release; this measure will then be compared between cocaine-dependent and control subjects. We will also measure plasma cortisol and ACTH), physiological measures, and subjective craving and mood.
- Being tested
- Corticotropin-Releasing Hormone
- Keywords
- Cocaine, Substance-Related Disorders, Drug Addiction, Substance Addiction, Dopamine, Receptors, Dopamine D2, Receptors, Dopamine D3, Stress, Psychological, Corticorelin, Neuroendocrine System, Cortisol, Adrenocorticotropic Hormone, Positron-Emission Tomography, 11C-PHNO
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticotropin-Releasing HormoneDrug
Also called corticorelin
Each subject will receive a single dose of Corticotropin-Releasing Hormone corticorelin on a single occasion, and a volume-matched saline injection on a second occasion. Corticorelin will be administered as an intravenous infusion over a 30- to 60-second interval at a dose of 1 ug/kg body weight. ~15 minutes after Corticorelin/saline injection, [11C]-(+)-PHNO will be administered followed by 90 minutes of PET scanning. Primary outcome measure ([11C]-(+)-PHNO) as well as Secondary outcome measures (self reported feeling, hormones and physiological measures) will be obtained before saline or Corticorelin/saline injection and for 90-120 minutes following injection.
| Study group | Role | What they receive |
|---|---|---|
| cocaine-dependent (CD) | cocaine-dependent individuals Receives: Drug: Corticotropin-Releasing Hormone | |
| healthy control (HC) | healthy age and sex-matched individuals who do not use cocaine Receives: Drug: Corticotropin-Releasing Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET measure: [11C]-(+)-PHNO binding
[11C]-(+)-PHNO binding on two occasions (following corticorelin and saline)
Measured: within a month following enrollment
Secondary outcomes (4)
stress hormone levels
plasma cortisol, ACTH
Measured: in conjunction with PET
subjective measures
subjective stress, craving, mood, drug effects
Measured: in conjunction with PET
vital signs
heart rate, blood pressure
Measured: in conjunction with PET
neuropsychological battery
battery of neuropsychological tasks to assess cognitive function, general intelligence, and personality.
Measured: once following PET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionJun 2016
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 Centre for Addiction and Mental HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Boileau, Centre for Addiction and Mental Health
- Investigators
- Isabelle Boileau, PhD, Principal investigator, Centre for Addiction and Mental Health, Research Imaging Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984177
- Sponsor's protocol ID
- 010/2012
- Status last verified
- Aug 2016
- First submitted
- 9 Oct 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence: A [11C]-(+)-PHNO PET Investigation
- ClinicalTrials.gov ID
- NCT01984177
- Acronym / sponsor ID
- 010/2012
- Keywords
- Cocaine, Substance-Related Disorders, Drug Addiction, Substance Addiction, Dopamine, Receptors, Dopamine D2, Receptors, Dopamine D3, Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Nov 2013 (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.
This study will, in a sample of cocaine-dependent and healthy control subjects, administer corticorelin and compare dopamine release between groups. Dopamine release will be measured using PET neuroimaging with the radiotracer [11C]-(+)-PHNO.
Detailed description
SCIENTIFIC SUMMARY The project will, in a sample of cocaine-dependent (CD) and healthy control (HC) subjects, use administration of Corticorelin, a synthetic form of corticotropin releasing factor (CRF)and PET imaging to assess dopamine (DA) transmission in addiction. We will use [11C]-(+)-PHNO PET to measure striatal DA receptor binding on two occasions: 1) following corticorelin administration and 2) following saline. The change in receptor binding between the two occasions (i.e., displacement of [11C]-(+)-PHNO by endogenous DA) will index DA release.
SUBJECTS CD subjects will meet DSM-IV criteria for abuse or dependence and be ~10d cocaine abstinent at the time of PET. HC will be recruited to match CD on age, sex, education, and cigarette smoking.
PRIMARY OUTCOME MEASURES We will measure [11C]-(+)-PHNO binding on two occasions (corticorelin, saline), with the difference between conditions indexing dopamine release; this measure will then be compared between cocaine-dependent and control subjects. We will also measure plasma cortisol and ACTH), physiological measures, and subjective craving and mood.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cocaine-dependent (CD) | – | Drug: Corticotropin-Releasing Hormonecocaine-dependent individuals |
| healthy control (HC) | – | Drug: Corticotropin-Releasing Hormonehealthy age and sex-matched individuals who do not use cocaine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CD subjects are recruited from the local community using flyers and internet advertisements, and through referral from local clinical programs. CD subjects are recruited from the community using flyers and internet advertisements.
Key inclusion criteria (5 listed)
- Sign and date informed consent
- Willing and able to complete trial as described in the protocol
- Psychiatrically healthy (as per diagnostic interview) except for cocaine dependence in cocaine users and nicotine dependence in both groups
- Mentally healthy
- Medically healthy (as per medical exam) with no current use of medications that may interfere with hormone activity or psychological measurements
Key exclusion criteria (7 listed)
- Axis I psychiatric disorder (as per diagnostic interview), or medical condition that might interfere with participation in the study (as per medical exam)
- Exposure to radiation in the last 12 months exceeding the amount permissible by the CAMH PET centre
- Have received synthetic glucocorticoid or exogenous steroid therapy within one month of testing
- Exceed normal body weight
- If female: pregnancy or breast-feeding
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 |
|---|---|---|
| Corticotropin-Releasing HormoneAlso: corticorelinEach subject will receive a single dose of Corticotropin-Releasing Hormone corticorelin on a single occasion, and a volume-matched saline injection on a second occasion. Corticorelin will be administered as an intravenous infusion over a 30- to 60-second interval at a dose of 1 ug/kg body weight. ~15 minutes after Corticorelin/saline injection, [11C]-(+)-PHNO will be administered followed by 90 minutes of PET scanning. Primary outcome measure ([11C]-(+)-PHNO) as well as Secondary outcome measures (self reported feeling, hormones and physiological measures) will be obtained before saline or Corticorelin/saline injection and for 90-120 minutes following injection. | Drug | cocaine-dependent (CD), healthy control (HC) |
Primary outcome
PET measure: [11C]-(+)-PHNO binding
Time frame: within a month following enrollment
[11C]-(+)-PHNO binding on two occasions (following corticorelin and saline)
4 secondary outcomes
stress hormone levels
Time frame: in conjunction with PET
subjective measures
Time frame: in conjunction with PET
vital signs
Time frame: in conjunction with PET
neuropsychological battery
Time frame: once following PET
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 9 Aug 2016.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating CentreLink provided by the sponsor.
Related trials for Cocaine-Related Disorders
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Active, not recruitingEarly Phase 1
Targeting Drug Memories With Methylphenidate
Substance Use Disorder, Cocaine Use Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
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.
Isabelle Boileau, PhD principal investigator
Centre for Addiction and Mental Health, Research Imaging Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine-Related Disorders and Cocaine Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 5 inclusion and 7 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 9 Aug 2016. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
PET measure: [11C]-(+)-PHNO binding (time frame: within a month following enrollment). 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 9 Aug 2016.