Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to… (NCT02639273) | Clinical Trial Compass
CompletedPhase 1
Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
United States13 participantsStarted 2016-06-08
Plain-language summary
Background:
Drugs like nalmefene interfere with opioid receptors. This might reduce drinking. The gene OPRM1 determines opioid receptor functions. Researchers want to see if nalmefene affects people s responses to alcohol cues. They also want to compare how nalmefene affects people with different forms of OPRM1.
Objectives:
To test nalmefene s effects on alcohol self-infusion and responses to alcohol cues. To test the role of different forms of OPRM1 on these effects.
Eligibility:
Healthy heavy drinkers ages 21 60:
Women: over 15 drinks weekly
Men: over 20 drinks weekly
Design:
Participants will be screened with:
Medical history
Physical exam
Heart, blood, and urine tests
Questionnaires
Participants will have three 10-hour visits and one 2-hour follow-up visit. They will take a taxi. Visits are about 1 week apart.
Before visits, participants cannot drink alcohol for 1 day or take medicine for 3 days.
All study visits:
Questionnaires
Heart monitor
Two-hour alcohol session: A needle guides a thin plastic tube into a vein in each arm. One tube receives alcohol. The other draws blood. Participants give themselves alcohol by pressing a button on a computer.
Relaxing at the center until breath alcohol falls below 0.02 percent, or for 3 hours.
Visits 2 and 3:
Swallowing nalmefene or placebo.
One-hour brain MRI: Participants lie on a table with a coil on their head. They press buttons in response to computer cues.
Follow-up visit: participants will discuss their drinking habits.
Who can participate
Age range
21 Years – 60 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.
* ELIGIBILITY CRITERIA:
Participants will be healthy 21-60 year-old male and female heavy drinkers. An equal number of participants with OPRM 118 AA genotype and those with 1 or 2 copies of the G allele (AG or GG) will be enrolled. Inclusion and exclusion criteria will be evaluated following screening conducted under the NIAAA screening protocol as described below
INCLUSION:
* Male and female participants between 21-60 years of age.
* Male participants must have consumed an average of greater than 14 standard drinks per week, and females must have consumed an average of greater than 7 standard drinks per week during the past 3 months \[assessment: 90-day timeline followback (TLFB)completed at screening visit\].
* In addition, participants must have on average at least 1 binge drinking day per week during the last 90 days, defined as a day in which 4 or more standard drinks were consumed for females and 5 or more standard drinks were consumed for males. Average number of binge drinking days will be calculated based on total number of binge drinking days from the TLFB (e.g., for 90 days worth of data, participants with a total of 13 or more binge drinking days will be eligible).
* Participants must be willing and able to refrain from using alcohol one day prior to each study, and non-prescription medication for 3 days prior to each visit \[assessment: medical history\].
* Inclusion criteria for women:
* Use of adequate method of birth control during the study, if female i…
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
Nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula
Timeframe: Post-administration
2
Nalmefene-induced changes in IV alcohol self-administration
Timeframe: Post-administration
Trial details
NCT IDNCT02639273
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)