AUDPhase 1NCT02639273
Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
A Phase 1 study testing Nalmefene in people with AUD, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- AUD
- What is being tested?
- Nalmefene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2016to 8 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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].
- Use of adequate method of birth control during the study, if female is sexually active and is not surgically sterilized. Adequate methods of contraception include: use of oral contraceptives; use of barrier method of contraceptive; use of an approved IUD or other long-acting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s) [assessment: medical history].
Who cannot join
- Current or prior history of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders [assessment: clinically significant findings on medical history and physical exam, ECG, laboratory tests].
- Participation in any other pharmacological intervention study within 4 months prior to the start of this study [assessment: medical history].
- Positive hepatitis A, B Antigen, or C, or HIV test [assessment: laboratory test].
- An aspartate transaminase (AST) / alanine transaminase (ALT) ratio 3 times greater than the normal limit [assessment: laboratory test].
- Diagnosis of Axis-I anxiety disorders or major depressive disorders in the past 12 months [assessment: SCID interview].
- Lifetime diagnosis of Axis-I bipolar disorders or psychotic disorders [assessment: SCID interview].
Show all 24Show fewer
- Suicidal ideation in the past 6 months or suicidal behavior in the past 12 months [assessment: Columbia Suicide Severity Rating Scale].
- Current diagnosis of substance use disorder (SUD), other than alcohol use disorder, mild cannabis use disorder (less than 4 criteria), or current SUD in remission. Current smoking or nicotine dependence is not exclusionary [assessment: SCID-IV/SCID-5 interview, FTND].
- Positive result on urine drug screen or breathalyzer test during screening. Positive urine drug screen or breathalyzer reading during more than 1 study visit will result in participant withdrawal from the study [assessment: laboratory tests and breathalyzer test performed at screening or update visit under 14-AA-0181 most proximal to enrollment].
- Currently (i.e., at the time of screening) seeking treatment for alcohol problems or have undergone inpatient or outpatient detoxification or treatment for alcohol problems in the past 6 months. [assessment: medical history and physical exam].
- Lactose intolerance or rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption [assessment: medical history and physical exam].
- Alcohol use:
- Current or prior history of alcohol-induced flushing reaction, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks [assessment: medical history and physical exam, alcohol flushing questionnaire].
- History of delirium tremens, hallucinations or seizures related to alcohol withdrawal [assessment: medical history, CIWA-Ar, SCID interview].
- Medication exclusion criteria:
- Any regular or prescribed use of opioid analgesics in the past 3 months.
- Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, opioid analgesics including darvocet, percocet and hydrocodone, cough-and-cold preparations which contain anti-histamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen.
- Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram.
- Use of drugs known to affect hemodynamic response. These include antihypertensives, insulin and thyroid medications. [assessment: medical history and physical exam].
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments).
- Fear of enclosed spaces.
- Inability to lie comfortable on back for up to 2 hours in the MRI scanner [assessment: NIAAA MRI Safety Screening Questionnaire].
- Pregnant [assessment: urine beta-hCG test at screening]. Women must also test negative on urine beta-hCG test at the start of every study visit.
- Breast-feeding [assessment: medical history and physical exam].
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
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.
Read more
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.
Read the detailed description
Previous studies have shown that the opioid receptor modulator nalmefene can reduce heavy drinking among alcoholics. Genetic variation at the micro-opioid receptor gene locus, OPRM1, specifically the A118G polymorphism, is associated with differential subjective responses to alcohol. Further, the A118G polymorphism has been shown to moderate the effect of opioid receptor modulators on alcohol consumption. However, the role of A118G on nalmefene s effectivenes, and the neural substrates underlying nalmefene s therapeutic effect remain to be explored in humans.
Objective: To evaluate the effect of nalmefene on alcohol self-infusion and neural response to alcohol cues in healthy male and female heavy drinkers, and to examine the role of the OPRM1 A118G polymorphism on this effect.
Study population: Participants will be 21-60 year-old male and female heavy drinkers in good health, as determined by medical history, physical exam, and ECG and lab tests. Participants with current Axis-I mood, anxiety or substance use diagnoses, except alcohol dependence, will be excluded. Participants will be divided into 2 genotypic groups: Group 1 (AA) will include participants homozygous for the major 118A allele (118AA genotype), and group 2 (GX) will include participants carrying 1 or 2 copies of the variant 118G allele (118AG or 118GG genotype).
Design: Participants will undergo 3 study sessions. In the first session, participants will complete an intravenous alcohol self-administration (IV-ASA) where they will have an open bar phase to determine their baseline level of alcohol consumption in the laboratory, as well as to obtain data on tolerability and subjective measures of alcohol effects. In the second and third sessions, participants will receive a single dose of either nalmefene or placebo, in counter-balanced order, before completing functional magnetic resonance imaging (fMRI) scans and IV-ASA procedures. The fMRI scans will include a task where participants will see cues that indicate the possibility of earning alcohol rewards to examine the neural substrates involved in processing alcohol cues, and a task designed to measure neural responses during anticipation and processing of aversive events. The difference in alcohol self-infusions between the two sessions will be compared between the two genotypic groups.
Outcome measures: The primary outcome measures are: (1) nalmefene-induced changes in IV alcohol self-administration; (2) nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula.;Secondary outcome measures include: (1) Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI; (2) Genotypic modulation (at the OPRM1 118 location) of nalmefene s effects on primary outcome measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).
- Conditions
- AUD
- Being tested
- Nalmefene, Placebo
- Keywords
- Alcohol Infusion study, Nalmefene, fMRI, Genetics, NIAAA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalmefeneDrug
Active Drug
PlaceboOther
Single Dose Placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | single dose nalmefene Receives: Drug: Nalmefene |
| Placebo | Placebo comparator | single dose placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula
functional MRI measure of brain activation.
Measured: Post-administration
Nalmefene-induced changes in IV alcohol self-administration
human laboratory alcohol consumption measure.
Measured: Post-administration
Secondary outcomes (2)
Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI
functional MRI measure of brain activation.
Measured: Post-adminstration
Genotypic modulation (at the OPRM1 118 location) of Nalmafene's effects on primary outcome measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).
human laboratory alcohol consumption measure.
Measured: Post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start8 Jun 2016
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AUDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vijay A Ramchandani, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639273
- Sponsor's protocol ID
- 160037
- Other IDs
- 16-AA-0037
- Status last verified
- 7 Oct 2026
- First submitted
- 23 Dec 2015
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gowin JL, Sloan ME, Kirk-Provencher KT, Rosenblatt SL, Penner AE, Stangl BL, Byrd ND, Swan JE, Ramchandani VA. Opioid receptor antagonism and neural response to monetary rewards: Pilot studies in light and heavy alcohol users. J Psychopharmacol. 2023 Sep;37(9):937-941. doi: 10.1177/02698811231191707. Epub 2023 Aug 2.
PubMed 37530456
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
- ClinicalTrials.gov ID
- NCT02639273
- Acronym / sponsor ID
- 160037
- Conditions
- AUD
- Keywords
- Alcohol Infusion study, Nalmefene, fMRI, Genetics, NIAAA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Previous studies have shown that the opioid receptor modulator nalmefene can reduce heavy drinking among alcoholics. Genetic variation at the micro-opioid receptor gene locus, OPRM1, specifically the A118G polymorphism, is associated with differential subjective responses to alcohol. Further, the A118G polymorphism has been shown to moderate the effect of opioid receptor modulators on alcohol consumption. However, the role of A118G on nalmefene s effectivenes, and the neural substrates underlying nalmefene s therapeutic effect remain to be explored in humans.
Objective: To evaluate the effect of nalmefene on alcohol self-infusion and neural response to alcohol cues in healthy male and female heavy drinkers, and to examine the role of the OPRM1 A118G polymorphism on this effect.
Study population: Participants will be 21-60 year-old male and female heavy drinkers in good health, as determined by medical history, physical exam, and ECG and lab tests. Participants with current Axis-I mood, anxiety or substance use diagnoses, except alcohol dependence, will be excluded. Participants will be divided into 2 genotypic groups: Group 1 (AA) will include participants homozygous for the major 118A allele (118AA genotype), and group 2 (GX) will include participants carrying 1 or 2 copies of the variant 118G allele (118AG or 118GG genotype).
Design: Participants will undergo 3 study sessions. In the first session, participants will complete an intravenous alcohol self-administration (IV-ASA) where they will have an open bar phase to determine their baseline level of alcohol consumption in the laboratory, as well as to obtain data on tolerability and subjective measures of alcohol effects. In the second and third sessions, participants will receive a single dose of either nalmefene or placebo, in counter-balanced order, before completing functional magnetic resonance imaging (fMRI) scans and IV-ASA procedures. The fMRI scans will include a task where participants will see cues that indicate the possibility of earning alcohol rewards to examine the neural substrates involved in processing alcohol cues, and a task designed to measure neural responses during anticipation and processing of aversive events. The difference in alcohol self-infusions between the two sessions will be compared between the two genotypic groups.
Outcome measures: The primary outcome measures are: (1) nalmefene-induced changes in IV alcohol self-administration; (2) nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula.;Secondary outcome measures include: (1) Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI; (2) Genotypic modulation (at the OPRM1 118 location) of nalmefene s effects on primary outcome measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Nalmefenesingle dose nalmefene |
| Placebo | Placebo comparator | Other: Placebosingle dose placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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].
Key exclusion criteria (24 listed)
- Current or prior history of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders [assessment: clinically significant findings on medical history and physical exam, ECG, laboratory tests].
- Participation in any other pharmacological intervention study within 4 months prior to the start of this study [assessment: medical history].
- Positive hepatitis A, B Antigen, or C, or HIV test [assessment: laboratory test].
- An aspartate transaminase (AST) / alanine transaminase (ALT) ratio 3 times greater than the normal limit [assessment: laboratory test].
- Diagnosis of Axis-I anxiety disorders or major depressive disorders in the past 12 months [assessment: SCID interview].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalmefeneActive Drug | Drug | Drug |
| PlaceboSingle Dose Placebo | Other | Placebo |
Primary outcome
Nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula
Time frame: Post-administration
functional MRI measure of brain activation.
Nalmefene-induced changes in IV alcohol self-administration
Time frame: Post-administration
human laboratory alcohol consumption measure.
2 secondary outcomes
Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI
Time frame: Post-adminstration
Genotypic modulation (at the OPRM1 118 location) of Nalmafene's effects on primary outcome measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).
Time frame: Post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 37530456Gowin JL, Sloan ME, Kirk-Provencher KT, Rosenblatt SL, Penner AE, Stangl BL, Byrd ND, Swan JE, Ramchandani VA. Opioid receptor antagonism and neural response to monetary rewards: Pilot studies in light and heavy alcohol users. J Psychopharmacol. 2023 Sep;37(9):937-941. doi: 10.1177/02698811231191707. Epub 2023 Aug 2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay A Ramchandani, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nalmefene in people with AUD, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula (time frame: Post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.