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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Cocaine Addiction Substance-Related Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cocaine-dependent (CD)

cocaine-dependent individuals

Corticotropin-Releasing Hormone

Intervention Type DRUG

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.

healthy control (HC)

healthy age and sex-matched individuals who do not use cocaine

Corticotropin-Releasing Hormone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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corticorelin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes