Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Northern California Institute of Research and Education | OTHER |
| San Francisco Veterans Affairs Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.
This is a pilot controlled clinical trial that aims to assess the efficacy of N-acetylcysteine (NAC) to reduce alcohol use and improve brain injury symptoms in Veterans with mTBI who consume alcohol at hazardous or harmful levels.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Experimental | N-acetylcysteine capsules daily - up to 3200 mg |
|
| Placebo | Placebo Comparator | Placebo capsules daily - up to 3200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Management Counseling | Behavioral | Brief alcohol counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) | The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. | Baseline to Week 8 |
| Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI) | Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms | Baseline to Week 8 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB) | The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. | Baseline to Week 8 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven L. Batki, MD | Unviersity of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | N-acetylcysteine | N-acetylcysteine capsules daily - up to 3200 mg Medical Management Counseling: Brief alcohol counseling N-acetylcysteine: Experimental supplement |
| FG001 | Placebo | Placebo capsules daily - up to 3200 mg Medical Management Counseling: Brief alcohol counseling Placebo: Placebo comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | N-acetylcysteine | N-acetylcysteine capsules daily - up to 3200 mg Medical Management Counseling: Brief alcohol counseling N-acetylcysteine: Experimental supplement |
| BG001 | Placebo |
| 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 | Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) | The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. | Posted | Mean | Standard Deviation | change in percent heavy drinking days/wk | Baseline to Week 8 |
|
Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-acetylcysteine | N-acetylcysteine capsules daily - up to 3200 mg Medical Management Counseling: Brief alcohol counseling N-acetylcysteine: Experimental supplement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization for self-reported "broken back in 3 places". | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven L. Batki, MD | University of California, San Francisco/San Francisco VA Healthcare System | 415-221-4810 | 23671 | steven.batki@ucsf.edu |
Not provided
| 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 | Oct 30, 2017 | Jun 1, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2017 | May 14, 2020 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Institute for Translational Neuroscience |
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
| N-acetylcysteine | Drug | Experimental supplement |
|
|
| Placebo | Drug | Placebo comparator |
|
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI) | Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Week 8 |
|
|
|
| Other Pre-specified | Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB) | The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week. | Posted | Mean | Standard Deviation | Standard drinks per week | Baseline to Week 8 |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| 14 |
| 14 |
| EG001 | Placebo | Placebo capsules daily - up to 3200 mg Medical Management Counseling: Brief alcohol counseling Placebo: Placebo comparator | 0 | 16 | 0 | 16 | 16 | 16 |
| Inpatient hospitalization/5150 (<72 hours) for suicidal threats while intoxicated | Psychiatric disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |