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Cocaine-Related Disorders | Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence

Cocaine-Related Disorders research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cocaine-Related Disorders

Cocaine Addiction

Substance-Related Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Corticotropin-Releasing HormoneEach 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

cocaine-dependent (CD)cocaine-dependent individuals

healthy control (HC)healthy age and sex-matched individuals who do not use cocaine

Study Status

Completed

Start Date: June 2013

Completed Date: June 2016

Phase: N/A

Type: Observational

Design:

Primary Outcome: PET measure: [11C]-(+)-PHNO binding

Secondary Outcome: stress hormone levels

Study sponsors, principal investigator, and references

Principal Investigator: Isabelle Boileau, PhD

Lead Sponsor: Centre for Addiction and Mental Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01984177

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