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Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01984177
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cocaine-Related Disorders Cocaine Addiction Substance-Related Disorders Drug: Corticotropin-Releasing Hormone

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

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence: A [11C]-(+)-PHNO PET Investigation
Study Start Date : June 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
cocaine-dependent (CD)
cocaine-dependent individuals
Drug: Corticotropin-Releasing Hormone
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.
Other Name: corticorelin
healthy control (HC)
healthy age and sex-matched individuals who do not use cocaine
Drug: Corticotropin-Releasing Hormone
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.
Other Name: corticorelin


Outcome Measures

Primary Outcome Measures :
  1. PET measure: [11C]-(+)-PHNO binding [ Time Frame: within a month following enrollment ]
    [11C]-(+)-PHNO binding on two occasions (following corticorelin and saline)


Secondary Outcome Measures :
  1. stress hormone levels [ Time Frame: in conjunction with PET ]
    plasma cortisol, ACTH

  2. subjective measures [ Time Frame: in conjunction with PET ]
    subjective stress, craving, mood, drug effects

  3. vital signs [ Time Frame: in conjunction with PET ]
    heart rate, blood pressure

  4. neuropsychological battery [ Time Frame: once following PET ]
    battery of neuropsychological tasks to assess cognitive function, general intelligence, and personality.


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984177


Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Isabelle Boileau, PhD Centre for Addiction and Mental Health, Research Imaging Centre
More Information

Additional Information:
Responsible Party: Isabelle Boileau, Clinical Research Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01984177     History of Changes
Other Study ID Numbers: 010/2012
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Isabelle Boileau, Centre for Addiction and Mental Health:
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

Additional relevant MeSH terms:
Disease
Behavior, Addictive
Cocaine-Related Disorders
Substance-Related Disorders
Pathologic Processes
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Hormones
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Cocaine
Dopamine
Dopamine Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Cardiotonic Agents
Sympathomimetics