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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA027486-01 | U.S. NIH Grant/Contract | View source | |
| 1U01AA027487 | 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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AUDs are difficult to treat, and relapse rates are high, with an estimated 80% of individuals with AUDs returning to alcohol use after completing addictions treatment. Novel treatment approaches are needed to enhance long term sobriety. The investigator's research team has been investigating the use of acamprosate to prevent relapse to alcohol use. Unfortunately despite being FDA approved and endorsed by the American Psychiatric Association only 10% of patients treated for AUD are prescribed acamprosate or other antidipsotropic medications. The number is higher for patients treated in programs affiliated with Mayo Clinic Addiction Services (approximately 20%) but is way less than expected. The most common reasons behind these low numbers are the understanding that not every patient benefits from the use of specific medication and the lack of biomarkers predictive of response. The purpose of this project is to identify such biomarkers by discovery of genomic and metabolomic markers associated with response to acamprosate treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acamprosate | Active Comparator | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia. |
|
| Placebo | Placebo Comparator | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Will be defined as continuous sobriety (yes/no) during 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor M Karpyak, MD, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hazelden Betty Ford Foundation | Center City | Minnesota | 55012 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Participants were evaluated by PRISM to confirm alcohol use disorder diagnosis and no secondary diagnosis of active other substance use disorder was present. Additional testing was done for renal impairment and advanced liver disease. Participants were required to be willing to stop chronic/daily use of prescribed benzodiazepines, opioids, stimulants, cannabis related medication such as CBD or medical marijuana during participation. Review of medications including anti-depressants was done.
Recruitment for the study began in June of 2019 and continued to July 2023 with follow-up visits completed in October 2023. All participants were recruited while attending a residential intensive treatment program.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acamprosate | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia. Acamprosate: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
| FG001 | Placebo | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. Placebo: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acamprosate | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia. Acamprosate: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | The analyzed sample included participants that completed 3 months of the study, as well as, those that dropped out but were known to have relapsed before 3 months. | Posted | Count of Participants | Participants | Will be defined as continuous sobriety (yes/no) during 3 months of treatment |
|
Adverse event data was collected up to 3 months during each patient's participation.
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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 | Acamprosate | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia. Acamprosate: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER/Hospital visit for suicidal ideation, intoxication, or alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
Inpatient treatment centers were closed for a period of time and subsequently admission numbers were decreased to accommodate social distancing requirements during the COVID pandemic leading to lower recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor Karpyak, MD, PhD | Mayo Clinic | (507)284-8891 | karpyak.victor@mayo.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 9, 2023 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Placebo | Other | The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
|
| The number of days until first alcohol use (relapse) assessed by TLFB during 3 months of treatment |
| Days Until First Relapse (Heavy Relapse) - Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Number of days until first relapse (heavy relapse) between medication start and 3 months follow-up |
| Cumulative Abstinence Duration - Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Cumulative abstinence duration proportion: proportion of days over the length of 3 month follow-up during which participants were abstinent from alcohol use, a score range of 0 (drinking continuously) to 100 (maintain complete abstinence) is applied. |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Hazelden Betty Ford Foundation | Newberg | Oregon | 97132 | United States |
| BG001 | Placebo | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. Placebo: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. Placebo: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. |
|
|
| Secondary | Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Posted | Median | Inter-Quartile Range | Number of days | The number of days until first alcohol use (relapse) assessed by TLFB during 3 months of treatment |
|
|
|
| Secondary | Days Until First Relapse (Heavy Relapse) - Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Posted | Median | Inter-Quartile Range | Number of days | Number of days until first relapse (heavy relapse) between medication start and 3 months follow-up |
|
|
|
| Secondary | Cumulative Abstinence Duration - Timeline Follow Back | The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date. | Posted | Mean | Standard Deviation | percentage of days | Cumulative abstinence duration proportion: proportion of days over the length of 3 month follow-up during which participants were abstinent from alcohol use, a score range of 0 (drinking continuously) to 100 (maintain complete abstinence) is applied. |
|
|
|
| 0 |
| 184 |
| 0 |
| 184 |
| 55 |
| 184 |
| EG001 | Placebo | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. Placebo: The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. | 0 | 104 | 0 | 104 | 35 | 104 |
| Loss of sexual interest or problems with erection or achieving orgasm | Reproductive system and breast disorders | Systematic Assessment |
|
| Prolonged QT interval | Cardiac disorders | Systematic Assessment |
|
| Headache/Migraine | Nervous system disorders | Systematic Assessment |
|
| Cold/Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Jaw and Ear Pain, Broken Jaw | General disorders | Systematic Assessment |
|
| Difficulty Sleeping | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Seizure - no loss of consciousness | Nervous system disorders | Systematic Assessment | Patient with history of seizure |
|
| Restless legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Side effects of Lexapro | Psychiatric disorders | Systematic Assessment |
|
| Sciatica | Nervous system disorders | Systematic Assessment |
|
| Assault | Social circumstances | Systematic Assessment |
|
| GI virus, upset, Diarrhea, gas | Gastrointestinal disorders | Systematic Assessment |
|
| Smashed Finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain/feeling achy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin Peeling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depression, increased depressive thoughts and feelings | Psychiatric disorders | Systematic Assessment |
|
| Urinary symptoms - frequency | Renal and urinary disorders | Systematic Assessment |
|
| Cholecystitis | Surgical and medical procedures | Systematic Assessment |
|
| Poor concentration | Psychiatric disorders | Systematic Assessment |
|
| Decreased energy | Psychiatric disorders | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | Systematic Assessment |
|
| Increased score in suicidal thoughts question | Psychiatric disorders | Systematic Assessment | Patient Health Questionnaire-9 (PHQ-9) individual score of suicidal thoughts question was non-zero from previous assessments. |
|
| Fainting during blood draw | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Edema/bloating after starting meds & increased on full dose | Skin and subcutaneous tissue disorders | Systematic Assessment | Gabapentin started same day as study med |
|
| Altered mental status due to hepatic encephalopathy w/o coma | Psychiatric disorders | Systematic Assessment |
|
| Skin Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Relapse - alcohol consumption | Psychiatric disorders | Systematic Assessment | Reported from subjects who remained engaged in study participation. |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Red Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Face swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pulled Hamstring | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Piercing infection | Infections and infestations | Systematic Assessment |
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| Constipation | Renal and urinary disorders | Systematic Assessment |
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| Possible Acamprosate side effects | Product Issues | Systematic Assessment | sensitive gums, nausea, headache, too hot or too cold, loss of appetite, inflammation in the knee, overall tiredness |
|
| ED visit for tooth pain | General disorders | Systematic Assessment |
|
| Demyelination | Musculoskeletal and connective tissue disorders | Systematic Assessment | More than likely it's MS not sure at this time |
|
| Pt found unconscious & unresponsive 40-45 minutes after blood draw | Nervous system disorders | Systematic Assessment | consciousness returned and had 30 min of observation |
|
| Distress from symptoms with request that study psychiatrist contact them | Psychiatric disorders | Systematic Assessment |
|
| Shoulder injury/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chronic Knee injury (history of) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Requires surgery after discharge |
|
| Emotional upset | Psychiatric disorders | Systematic Assessment | Triggered by reviewing drinking history details and marijuana use questions from the PRISM & TLFB assessments |
|
| COVID 19 | Infections and infestations | Systematic Assessment |
|
| Patient Health Information (PHI) shared with non-study member | Social circumstances | Systematic Assessment | Email w/PHI sent to HBFF employee not IRB approved - notified employee & had it deleted before opening |
|
| Mouth injury and spitting blood | General disorders | Systematic Assessment |
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| Irritation, feelings of crabbiness | Psychiatric disorders | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ankle injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Requires surgery |
|
| Bruise around left eye | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Panic attack with disassociation | Psychiatric disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |