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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA015385-01 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone add on to valproate | Experimental | Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate |
|
| Placebo add on to valproate | Placebo Comparator | Placebo comparator one capsule daily for 12 weeks add on to valproate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone hydrochloride | Drug | Naltrexone hydrochloride 50 mg capsule daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % Subjects Abstinent | Proportion of subjects abstinent during the last 4 weeks of the trial | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ihsan M Salloum, MD, MPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
Total telephone screened included 696 inquiries: 517 excluded for not meeting initial screen criteria; 91 excluded for lost to follow-up with continuing screening; 88 enrolled into the study.
Of the 88 enrolled, 35 excluded for not meeting the inclusion criteria; 35 were lost to follow-up before group assignment.
Sample drawn from University-based mental health services, community treatment programs and advertisement
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | Naltrexone add on to valproate open label Naltrexone Hydrochloride 50 mg daily for 12 weeks |
| FG001 | Placebo | Placebo add on to valproate open label Placebo one capsule daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone | Naltrexone add on to valproate open label naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate |
| BG001 | Placebo |
| 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 | Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial | One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment. | Posted | Mean | Standard Deviation | standard drinks/drinking day | 12 weeks |
|
Adverse events reported by subjects during their participation in the study
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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 add on to valproate open label naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
High early drop-out rate leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ihsan Salloum, MD, MPH | University of Miami Miller School of Medicine | 305 243-7931 | isalloum@med.miami.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related 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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| Placebo | Other | Placebo arm |
|
Placebo add on to valproate open label
Placebo add on to open label valproate for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | TimeLine Follow-Back (TLFB) | Number | participants |
|
|
|
| Secondary | % Subjects Abstinent | Proportion of subjects abstinent during the last 4 weeks of the trial | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | Placebo | Placebo add on to valproate open label Placebo add on to open label valproate for 12 weeks | 0 | 9 | 5 | 9 |
| Palpitation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea/ diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal cramps | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced 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 |