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

NCT01984177 | Completed

• 1 other identifier: 010/2012
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine-Related Disorders; Cocaine Addiction; Substance-Related Disorders

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

Outcome Measures

Primary Outcomes (1)

• PET measure: [11C]-(+)-PHNO binding

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

  within a month following enrollment

Secondary Outcomes (4)

• stress hormone levels

  in conjunction with PET

• subjective measures

  in conjunction with PET

• vital signs

  in conjunction with PET

• neuropsychological battery

  once following PET

Study Arms (2)

cocaine-dependent (CD)

cocaine-dependent individuals

Drug: Corticotropin-Releasing Hormone

healthy control (HC)

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

Drug: Corticotropin-Releasing Hormone

Interventions

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.

Also known as: corticorelin

cocaine-dependent (CD); healthy control (HC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• 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 Centre

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Stress, Psychological

Interventions

Corticotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Isabelle Boileau, PhD

  Centre for Addiction and Mental Health, Research Imaging Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Scientist

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: November 14, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

CA (1)