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NCT Number: NCT01984177

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

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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Key information

Conditions

Cocaine-Related Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Cocaine Addiction Mental Disorders Stress, Psychological Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticotropin-Releasing Hormone

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.

Other names: corticorelin

Primary outcomes

  1. PET measure: [11C]-(+)-PHNO binding

    Time frame: within a month following enrollment

    [11C]-(+)-PHNO binding on two occasions (following corticorelin and saline)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence: A [11C]-(+)-PHNO PET Investigation

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2013
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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