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| ID | Type | Description | Link |
|---|---|---|---|
| K24AA016555 | 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 proposed design is a single-group open-label trial. Qualified consenting participants with active alcohol dependence and primary or secondary anxiety disorder will receive monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM) model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16. Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine treatment, with specific options for each disorder described in the protocol. Participants requiring continued treatment are referred to clinical treatment in the community at week 16, and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA) and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton Anxiety Scale scores and anxiety disorder diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disulfiram plus lorazepam | Experimental | Disulfiram plus lorazepam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disulfiram plus lorazepam | Drug | Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence | Completion of 16 weeks of disulfiram treatment | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days Abstinent From Alcohol (Intent-to-treat Sample) | As measured by Timeline Followback | Weeks 13-16 (Last 4 weeks of treatment) |
| Categorical Abstinence (Intent-to-treat Sample) | As measured by timeline followback |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P. Bogenschutz, M. D. | University of New Mexico Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Addiction and Substance Abuse Programs | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Disulfiram Plus Lorazepam | Disulfiram plus lorazepam disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Disulfiram Plus Lorazepam | Disulfiram plus lorazepam disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily |
| 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 | Treatment Adherence | Completion of 16 weeks of disulfiram treatment | Intent-to-treat | Posted | Count of Participants | Participants | 16 weeks |
|
|
24 weeks following first administration of study medication
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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 | Disulfiram Plus Lorazepam | Disulfiram plus lorazepam disulfiram plus lorazepam: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusional state | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment | Resulted in hospitalization, resolved without sequellae. Investigator deemed the SAE unlikely to be related to study medication or other aspects of study participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bogenschutz | NYU Grossman School of Medicine | 505-999-9325 | Michael.Bogenschutz@nyulangone.org |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004221 | Disulfiram |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D004050 | Ditiocarb |
| D013859 | Thiocarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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| Weeks 13-16 (Last 4 weeks of treatment) |
| Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16) | As measured by Timeline Followback | Weeks 13-16 (Last 4 weeks of treatment) |
| Categorical Abstinence (Among Those Observed at Week 16) | As measured by timeline followback | Weeks 13-16 (Last 4 weeks of treatment) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline proportion abstinent days | Timeline Followback | Mean | Standard Deviation | Percent |
|
| Baseline drinks per drinking day | Timeline Followback | Mean | Standard Deviation | Standard Drinks |
|
| Baseline estimated peak blood alcohol level | Timeline Followback | Mean | Standard Deviation | percent (mass/volume) |
|
|
| Secondary | Percent Days Abstinent From Alcohol (Intent-to-treat Sample) | As measured by Timeline Followback | Intent-to-treat sample (Baseline value imputed for missing values) | Posted | Mean | Standard Deviation | percentage of days abstinent | Weeks 13-16 (Last 4 weeks of treatment) |
|
|
|
| Secondary | Categorical Abstinence (Intent-to-treat Sample) | As measured by timeline followback | Percentage of 41 participants observed to be abstinent at week 16 (missing treated as non-abstinent) | Posted | Count of Participants | Participants | Weeks 13-16 (Last 4 weeks of treatment) |
|
|
|
| Secondary | Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16) | As measured by Timeline Followback | Participants observed at week 16 | Posted | Mean | Standard Deviation | Percent | Weeks 13-16 (Last 4 weeks of treatment) |
|
|
|
| Secondary | Categorical Abstinence (Among Those Observed at Week 16) | As measured by timeline followback | observed at week 16 | Posted | Count of Participants | Participants | Weeks 13-16 (Last 4 weeks of treatment) |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 28 |
| 40 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Alcohol intolerance | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment | Alcohol-disulfiram reaction |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Feelings of worthlessness | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004220 | Disulfides |
| D013440 | Sulfides |
| D013457 | Sulfur Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |