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Exploring Regulation and Function of Dopamine D3 Receptors in Alcohol Use Disorders: A [11C]-(+)-PHNO Study

NCT ID: NCT03037060

Last Updated: 2020-10-29

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

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-08-31

Brief Summary

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There is a need to better understand the mechanisms underlying alcohol use and dependence in order to advance the clinical treatment of alcohol dependence. Here, the investigators will use Positron Emission Tomography to determine if there is an up-regulation of D3 receptors in the brains of subjects with alcohol use disorders. The investigators will also investigate the relationship between D3 binding and major phenotypes associated with alcohol use disorders, namely: alcohol cue induced craving and motivation to self-administer alcohol in the laboratory.

Detailed Description

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Alcohol dependence is a devastating illness with social and medical costs estimated to be 180 billion dollars annually in the US. In the clinical treatment of alcoholism, reducing alcohol consumption in heavy drinkers is a major clinical challenge. As such, there has been much emphasis in both clinical and preclinical research to identify the substrates that mediate craving, excessive drinking and addiction. Identifying the neurobiological mechanisms of alcohol dependence may lead to the development of new and better treatment strategies. Preclinical studies indicate that the D3 receptor is involved in alcohol-cue response and in the motivation to drink alcohol. However, there is currently no data available in human subjects exploring the relationship between D3 and those behavioral responses in subjects with alcohol use disorders.

Aim #1: To measure the \[11C\]-(+)-PHNO PET binding levels in the brains of subjects with alcohol use disorders.

Aim #2: To determine the relationship between D3 receptor binding and alcohol cue induced craving and motivation to self-administer alcohol in the laboratory.

To achieve designated goals, the investigators will recruit 25 male and female subjects who are non-treatment seekers. After a period of abstinence from alcohol, participants will come to the Centre for Addiction of Mental Health for a \[11C\]-(+)-PHNO PET scan. Participants will also have additional sessions during which other alcohol-related measures will be assessed (i.e. alcohol cue induced craving and motivation to self-administer alcohol in the laboratory).

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental

5 experimental sessions per participant:

(1) \[11C\]-(+)-PHNO PET scan, (2), Alcohol Self-Administration, (3) Craving Task, (4) MRI scan and (5) Neuropsychological Assessment.

Group Type EXPERIMENTAL

[11C]-(+)-PHNO PET scan

Intervention Type OTHER

PET scan

Alcohol Self-Administration

Intervention Type OTHER

Session for assessing motivation for consuming alcohol.

Craving Task

Intervention Type OTHER

Cue exposure paradigm

MRI scan

Intervention Type OTHER

MRI scan scan to analyze the PET data will be administered.

Neuropsychological Assessment

Intervention Type OTHER

Cognitive questionnaires administered over course of study.

Interventions

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[11C]-(+)-PHNO PET scan

PET scan

Intervention Type OTHER

Alcohol Self-Administration

Session for assessing motivation for consuming alcohol.

Intervention Type OTHER

Craving Task

Cue exposure paradigm

Intervention Type OTHER

MRI scan

MRI scan scan to analyze the PET data will be administered.

Intervention Type OTHER

Neuropsychological Assessment

Cognitive questionnaires administered over course of study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects will meet diagnostic criteria for alcohol use disorder (mild through severe).
* Willing to abstain from drugs and alcohol prior to study visits
* A negative urine screen for illicit psychoactive drug use
* Willing and capable to provide written informed consent
* Willing to participate in cue exposure and intravenous alcohol administration sessions
* Male and female adults (at least 19 years old)

Exclusion Criteria

* DSM diagnosis of drug dependence other than alcohol
* Any severe Axis I disorder aside from alcohol use disorder
* Any medical condition requiring immediate investigation
* History of seizures, past or current neurological illness or serious head trauma
* Suicidal ideation
* Pregnancy tested by urine or blood screen or lactation
* Current past or anticipated exposure to radiation exceeding permissible limits as set by the CAMH PET Centre
* Metal implants or paramagnetic objects within the body which may interfere with the MRI
* Claustrophobia or a history of panic attacks
* Any other problem that, in the investigators' opinion, would preclude participation in trial (i.e., complicated withdrawal).
* Currently seeking treatment or attempting to reduce/quit drinking
* History of negative responses to venipuncture procedures (e.g., fainting/vasovagal response)
* Medications or medical disorders for which alcohol consumption is contraindicated
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Bernard Le Foll

Principal Investigator, MD, PhD, CCFP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Le Foll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre.

Other Identifiers

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052/2016

Identifier Type: -

Identifier Source: org_study_id