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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA021818-01A1 | U.S. NIH Grant/Contract | View source | |
| U54AA027989 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | Naltrexone 100 mg titrated over one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6-8 days after treatment with naltrexone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline prior to treatment with naltrexone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sac, Cmhc | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31399255 | Derived | de Laat B, Goldberg A, Shi J, Tetrault JM, Nabulsi N, Zheng MQ, Najafzadeh S, Gao H, Kapinos M, Ropchan J, O'Malley SS, Huang Y, Morris ED, Krishnan-Sarin S. The Kappa Opioid Receptor Is Associated With Naltrexone-Induced Reduction of Drinking and Craving. Biol Psychiatry. 2019 Dec 1;86(11):864-871. doi: 10.1016/j.biopsych.2019.05.021. Epub 2019 Jun 8. |
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All enrolled participants were assigned to a study arm.
Participants were recruited from the community through various methods such as flyers and online.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | Naltrexone: Naltrexone 100 mg titrated over one week |
| FG001 | Healthy Controls | No treatment, baseline measurements only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone | Naltrexone: Naltrexone 100 mg titrated over one week |
| BG001 | Healthy Controls | No treatment, baseline measurements only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | % Occupancy | 6-8 days after treatment with naltrexone |
|
|
Approximately 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone | Naltrexone: Naltrexone 100 mg titrated over one week | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Krishnan-Sarin | Yale University | 203.974.7595 | nicholas.franco@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2019 | May 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Naltrexone group | Jan 10, 2018 | May 20, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Healthy control group | Jan 10, 2018 | May 20, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Unable to complete study procedures |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | Posted | Number | percent probability | 6-8 days after treatment with naltrexone |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | % Occupancy | at baseline prior to treatment with naltrexone |
|
|
|
| 55 |
| 0 |
| 55 |
| 37 |
| 55 |
| EG001 | Healthy Controls | No treatment, baseline measurements only. | 0 | 4 | 0 | 4 | 0 | 4 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Cloudy | General disorders | Systematic Assessment |
|
| Cold sweat | General disorders | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypothermia | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased desired to drink | General disorders | Systematic Assessment |
|
| Decreased sex drive | Reproductive system and breast disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling high | General disorders | Systematic Assessment |
|
| Feeling good | General disorders | Systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Peeling hands | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment |
|
| Tightness in chest | General disorders | Systematic Assessment |
|
| Tired | General disorders | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Apetite change | Gastrointestinal disorders | Systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |