A Phase 1 interventional study of Naltrexone in Alcohol Drinking, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
The primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has been approved for the treatment of alcohol dependence. Receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking behavior. This study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. We will use PET (positron emission tomography) for this study. PET is a type of imaging device found in nuclear medicine. It is used for tracking the presence of injected radioactive materials in the body.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 59 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Drug: Naltrexone
Naltrexone 100 mg titrated over one week
Also known as: Revia
Occupancy of KOR by NTX and Drinking
To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
Time frame: 6-8 days after treatment with naltrexone
Relationship Between NTX Responsivity and Occupancy of KOR
To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers. Evaluations were done with a logistic regression which included years of drinking (a covariate), family history status, and occupancy of KOR. The logistic model calculated a probability of response, defined as a 50% or greater reduction in drinking after naltrexone, for every participant. Reported outcome is the area under the ROC produced by the model. The closer the value is to 100 percent probability, the better the model is at correctly classifying the observations.
Time frame: 6-8 days after treatment with naltrexone
Baseline KOR Differences
To determine if baseline levels of KOR differ between family history positive (FHP) and family history negative (FHN) heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.
Time frame: at baseline prior to treatment with naltrexone
Participants were recruited from the community through various methods such as flyers and online.
| Milestone | Naltrexone | Healthy Controls |
|---|---|---|
| Started | 55 | 4 |
| Pet scan 1 | 49 | 4 |
| Lab 2 | 48 | 0 |
| Pet scan 2 | 47 | 0 |
| Completed | 47 | 4 |
| Not completed | 8 | 0 |
| Withdrew: No adlib drinks lab 1 | 3 | 0 |
| Withdrew: Technical issues with pet | 1 | 0 |
| Withdrew: Unable to complete study procedures | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
| % Occupancy | Naltrexone |
|---|---|
| Occupancy of KOR by NTX and Drinking | 92 ± 1 |
To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers. Evaluations were done with a logistic regression which included years of drinking (a covariate), family history status, and occupancy of KOR. The logistic model calculated a probability of response, defined as a 50% or greater reduction in drinking after naltrexone, for every participant. Reported outcome is the area under the ROC produced by the model. The closer the value is to 100 percent probability, the better the model is at correctly classifying the observations.
| percent probability | Naltrexone |
|---|---|
| Relationship Between NTX Responsivity and Occupancy of KOR | 84 |
To determine if baseline levels of KOR differ between family history positive (FHP) and family history negative (FHN) heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.
| % Occupancy | Naltrexone - FH Positive | Naltrexone - FH Negative |
|---|---|---|
| Baseline KOR Differences | 91.2 ± 1.7 | 94.2 ± 1.9 |
Collected over Approximately 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naltrexone | 0/55 (0%) | 0/55 (0%) | 37/55 (67.3%) |
| Healthy Controls | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Event | Naltrexone | Healthy Controls |
|---|---|---|
| NauseaGastrointestinal disorders | 19/55 | 0/4 |
| HeadacheNervous system disorders | 9/55 | 0/4 |
| VomitingGastrointestinal disorders | 6/55 | 0/4 |
| DiarrheaGastrointestinal disorders | 6/55 | 0/4 |
| Apetite changeGastrointestinal disorders | 5/55 | 0/4 |
| FatigueGeneral disorders | 4/55 | 0/4 |
| Abdominal discomfortGastrointestinal disorders | 3/55 | 0/4 |
| AnxietyPsychiatric disorders | 3/55 | 0/4 |
| Decreased sex driveReproductive system and breast disorders | 3/55 | 0/4 |
| Feeling highGeneral disorders | 3/55 | 0/4 |
| Age, Continuous(years) | Naltrexone | Healthy Controls | Total |
|---|---|---|---|
| Mean | 32 ± 3.9 | 35.6 ± 11.4 | 33.8 ± 7.7 |
| Sex: Female, Male(Participants) | Naltrexone | Healthy Controls | Total |
|---|---|---|---|
| Female | 16 | 3 | 19 |
| Male | 31 | 1 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Naltrexone | Healthy Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 0 | 8 |
| Not Hispanic or Latino | 39 | 4 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Naltrexone | Healthy Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 0 | 22 |
| White | 24 | 4 | 28 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Naltrexone | Healthy Controls | Total |
|---|---|---|---|
| United States | 47 | 4 | 51 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Feb 2011, a primary completion of Jun 2021 and a completion of Jun 2021. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2022, 1 year 1 month after primary completion.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naltrexone