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This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX/BUP | Experimental | Oral naltrexone + sublingual buprenorphine |
|
| NTX/PBO-B | Active Comparator | Oral naltrexone + sublingual placebo |
|
| PBO-N/PBO-B | Placebo Comparator | Oral placebo naltrexone + sublingual placebo buprenorphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX/BUP | Drug | Daily doses |
| |
| NTX/PBO-B |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] \ | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria A. Sullivan, MD, PhD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Country Clinical Research | Oceanside | California | 92056 | United States | ||
| NRC Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29674251 | Result | Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend. 2018 Jun 1;187:171-178. doi: 10.1016/j.drugalcdep.2018.02.023. Epub 2018 Apr 10. | |
| 34752714 |
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Two subjects were randomized, but did not receive study drug. Four subjects attempted enrollment at multiple sites. The data collected on these subjects during their second enrollment was excluded from the efficacy analyses.
Adults with opioid use disorder who were voluntarily seeking treatment were eligible to enroll.
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| ID | Title | Description |
|---|---|---|
| FG000 | NTX/BUP | Oral naltrexone + sublingual buprenorphine NTX/BUP: Daily doses |
| FG001 | NTX/PBO-B | Oral naltrexone + sublingual placebo NTX/PBO-B: Daily doses |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Daily doses |
|
| PBO-N/PBO-B | Drug | Daily doses |
|
| 1 week |
| Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. | 1 week |
| Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. To determine the daily AUC COWS score, a curve was generated by plotting the COWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC COWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC COWS score was then divided by the number of days with daily AUC COWS score during the treatment period. The AUC COWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. | The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7) |
| Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection | The Desire for Opioids Visual Analog Scale (VAS) uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing "no desire for opioids" and 100 anchored on the right representing "strongest imaginable desire for opioids". Subjects placed a vertical line on the scale to indicate their desire for opioids at that particular time. | 1 week |
| Incidence of Adverse Effects | The number of subjects who experienced treatment-emergent Adverse Events. | Up to 92 days |
| Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection | The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). To determine the daily AUC SOWS score, a curve was generated by plotting the SOWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC SOWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC SOWS score was then divided by the number of days with daily AUC SOWS score during the treatment period. The AUC SOWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. | The SOWS was administered 4-6 times per day during the Treatment Period |
| Orange |
| California |
| 92868 |
| United States |
| Atlantic Shores Hospital | Lauderhill | Florida | 33308 | United States |
| TRY Research | Maitland | Florida | 84107 | United States |
| Research Centers of America | Oakland Park | Florida | 33334 | United States |
| CNS Healthcare | Orlando | Florida | 32801 | United States |
| Neuroscience Research Institute | Winfield | Illinois | 60190 | United States |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21224 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| PRA Health Sciences | Marlton | New Jersey | 08053 | United States |
| New York State Psychiatric Institute/ Columbia University | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | United States |
| Midwest Clinical Research Center, LLC | Dayton | Ohio | 45417 | United States |
| University Of Pennsylvania - Treatment Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| Western Psychiatric Institute and Clinic of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| Insite Clinical Research | DeSoto | Texas | 75115 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Pharmaceutical Research Associates Inc. | Salt Lake City | Utah | 32751 | United States |
| Mannelli P, Douaihy AB, Zavod A, Legedza A, Akerman SC, Sullivan MA. Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone. Am J Drug Alcohol Abuse. 2021 Nov 2;47(6):753-759. doi: 10.1080/00952990.2021.1969659. Epub 2021 Nov 9. |
| FG002 | PBO-N/PBO-B | Oral placebo naltrexone + sublingual placebo buprenorphine PBO-N/PBO-B: Daily doses |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety population included all subjects who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | NTX/BUP | Oral naltrexone + sublingual buprenorphine NTX/BUP: Daily doses |
| BG001 | NTX/PBO-B | Oral naltrexone + sublingual placebo NTX/PBO-B: Daily doses |
| BG002 | PBO-N/PBO-B | Oral placebo naltrexone + sublingual placebo buprenorphine PBO-N/PBO-B: Daily doses |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
| 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 | Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection | Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] \ | The Full Analysis Set (FAS) includes all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | Posted | Count of Participants | Participants | 1 week |
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| Secondary | Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. | The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | Posted | Mean | Standard Deviation | Number of days | 1 week |
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| Secondary | Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. | The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study). | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| Secondary | Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection | The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. To determine the daily AUC COWS score, a curve was generated by plotting the COWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC COWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC COWS score was then divided by the number of days with daily AUC COWS score during the treatment period. The AUC COWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. | All randomized subjects who received at least 1 dose of study drug and had 1 post-baseline COWS measurement. | Posted | Mean | Standard Deviation | Score on a scale | The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7) |
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| Secondary | Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection | The Desire for Opioids Visual Analog Scale (VAS) uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing "no desire for opioids" and 100 anchored on the right representing "strongest imaginable desire for opioids". Subjects placed a vertical line on the scale to indicate their desire for opioids at that particular time. | All randomized subjects who received at least 1 dose of study drug and provided at least 1 post-baseline measureable VAS assessment. | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| Secondary | Incidence of Adverse Effects | The number of subjects who experienced treatment-emergent Adverse Events. | The Safety Analysis Set was used to analyze this measure. | Posted | Count of Participants | Participants | Up to 92 days |
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| Secondary | Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection | The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). To determine the daily AUC SOWS score, a curve was generated by plotting the SOWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC SOWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC SOWS score was then divided by the number of days with daily AUC SOWS score during the treatment period. The AUC SOWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time. | All randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline SOWS measurement. | Posted | Mean | Standard Deviation | Score on a scale | The SOWS was administered 4-6 times per day during the Treatment Period |
|
Up to 92 days
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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 | NTX/BUP | Oral naltrexone + sublingual buprenorphine NTX/BUP: Daily doses | 0 | 126 | 2 | 126 | 18 | 126 |
| EG001 | NTX/PBO-B | Oral naltrexone + sublingual placebo NTX/PBO-B: Daily doses | 0 | 126 | 1 | 126 | 12 | 126 |
| EG002 | PBO-N/PBO-B | Oral placebo naltrexone + sublingual placebo buprenorphine PBO-N/PBO-B: Daily doses | 0 | 126 | 2 | 126 | 19 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic Attack | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Alcohol use | Social circumstances | MedDRA (18.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Stroynowski | Alkermes | 781-609-7000 | Eva.Stroynowski@alkermes.com |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio (OR) |
| 0.80 |
| Standard Error of the Mean |
| 0.207 |
| 2-Sided |
| 95 |
| 0.48 |
| 1.33 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | PBO-N/PBO-B | Oral placebo naltrexone + sublingual placebo buprenorphine PBO-N/PBO-B: Daily doses |
|
|
| Participants |
|
|
|
| OG002 | PBO-N/PBO-B | Oral placebo naltrexone + sublingual placebo buprenorphine PBO-N/PBO-B: Daily doses |
|
|