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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.
Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUP/VLNXT to VIVITROL | Experimental | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very low dose naltrexone | Drug | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Treatment | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS) | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Mannelli, MD | Duke University Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center / Civitan Building | Durham | North Carolina | 27705 | United States |
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38 participants signed consent. 3 participants were screen failures. 35 participants started study.
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| ID | Title | Description |
|---|---|---|
| FG000 | BUP/VLNXT to VIVITROL |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BUP/VLNXT to VIVITROL |
| 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 | Retention in Treatment | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks. | All participants who received the Extended Release Injectable NTX | Posted | Number | participants | 4 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 | BUP/VLNXT to VIVITROL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| persecutory ideations | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Withdrawal Symptoms | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Mannelli, M.D | Duke University Medical Center | 919-681-0613 | paolo.mannelli@dm.duke.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| extended release naltrexone | Drug | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
|
|
| buprenorphine/naloxone | Drug | On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg. |
|
|
| 4 weeks |
| Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms. | 4 weeks |
| Craving | Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving. | 4 weeks |
| Illicit Drug Use, Measured by Urine Drug Testing | number of participants that tested positive for marijuana, cocaine, and opiates. | 4 weeks |
| Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire | Questionnaire consisted of 3 questions.
Lower scores represent greater satisfaction. | Day 9 |
| Percentage of Participants Who Adhered to Study Visits. | baseline to end of study (approximately 40 days) |
| Percentage of Participants With Adherence to Medication (Naltrexone) | Participant who took Naltrexone as prescribed. | Day 1 to Day 8 (+/- 2 days) |
| Use of Ancillary Medications. | Number of participants that took ancillary medication | baseline to week 1 |
| Number of Participants That Self Reported Illicit Drug Use | Participants reported on any illicit drug use to include Cocaine marijuana opiates | 4 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Years of Opioid use | Mean | Full Range | years |
|
|
| Secondary | Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS) | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. | All participants who received the Extended Release Injectable NTX | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) | After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Craving | Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Illicit Drug Use, Measured by Urine Drug Testing | number of participants that tested positive for marijuana, cocaine, and opiates. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire | Questionnaire consisted of 3 questions.
Lower scores represent greater satisfaction. | Posted | Mean | Standard Deviation | units on a scale | Day 9 |
|
|
|
| Secondary | Percentage of Participants Who Adhered to Study Visits. | Posted | Number | percentage of participants | baseline to end of study (approximately 40 days) |
|
|
|
| Secondary | Percentage of Participants With Adherence to Medication (Naltrexone) | Participant who took Naltrexone as prescribed. | Posted | Number | percentage of participants | Day 1 to Day 8 (+/- 2 days) |
|
|
|
| Secondary | Use of Ancillary Medications. | Number of participants that took ancillary medication | Posted | Number | participants | baseline to week 1 |
|
|
|
| Secondary | Number of Participants That Self Reported Illicit Drug Use | Participants reported on any illicit drug use to include Cocaine marijuana opiates | Posted | Number | participants | 4 weeks |
|
|
|
| 1 |
| 35 |
| 6 |
| 35 |
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| 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 |
| D002047 | Buprenorphine |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|