Exploring Regulation and Function of Dopamine D3 Receptors in Alcohol Use Disorders: A [11C]-(+)-… (NCT03037060) | Clinical Trial Compass
CompletedNot Applicable
Exploring Regulation and Function of Dopamine D3 Receptors in Alcohol Use Disorders: A [11C]-(+)-PHNO Study
Canada17 participantsStarted 2016-12
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dopamine D2/D3 receptor occupancy
Timeframe: One PET scan after 2-7 days of abstinence from alcohol; ~2 hours in duration.