Brief Summary
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.
Brief Title
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria:
* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling to abide by the contraception requirements for the duration of the study
* Additional criteria may apply
Exclusion Criteria:
* Is pregnant, planning to become pregnant or breastfeeding during the study
* Has used Buprenorphine within 7 days prior to randomization
* Has used Methadone within 14 days prior to randomization
* Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
* Has a history of seizures or has received anticonvulsant therapy within the past 5 years
* Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
* Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
* Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
* Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone
* Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
* Has significant suicidal ideation or behavior within the past year
* Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
* Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
* Is court mandated to receive treatment for opioid use disorder
* Additional criteria may apply
* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling to abide by the contraception requirements for the duration of the study
* Additional criteria may apply
Exclusion Criteria:
* Is pregnant, planning to become pregnant or breastfeeding during the study
* Has used Buprenorphine within 7 days prior to randomization
* Has used Methadone within 14 days prior to randomization
* Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
* Has a history of seizures or has received anticonvulsant therapy within the past 5 years
* Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
* Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
* Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
* Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone
* Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
* Has significant suicidal ideation or behavior within the past year
* Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
* Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
* Is court mandated to receive treatment for opioid use disorder
* Additional criteria may apply
Inclusion Criteria
Inclusion Criteria:
* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling to abide by the contraception requirements for the duration of the study
* Additional criteria may apply
* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling to abide by the contraception requirements for the duration of the study
* Additional criteria may apply
Gender
All
Gender Based
false
Keywords
Alkermes
Buprenorphine
Naltrexone
Vivitrol
Opioid Use
Opiates
Dependence
Abuse
Heroin
Painkillers
Substance Abuse
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
18 Years
NCT Id
NCT02537574
Org Class
Industry
Org Full Name
Alkermes, Inc.
Org Study Id
ALK6428-A301
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®
Primary Outcomes
Outcome Description
Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The 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 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).
Outcome Measure
Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
Outcome Time Frame
1 week
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
1 week
Outcome Measure
Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection
Outcome Description
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.
Outcome Time Frame
1 week
Outcome Measure
Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection
Outcome Description
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.
Outcome Time Frame
The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7)
Outcome Measure
Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection
Outcome Description
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.
Outcome Time Frame
1 week
Outcome Measure
Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection
Outcome Description
The number of subjects who experienced treatment-emergent Adverse Events.
Outcome Time Frame
Up to 92 days
Outcome Measure
Incidence of Adverse Effects
Outcome Description
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.
Outcome Time Frame
The SOWS was administered 4-6 times per day during the Treatment Period
Outcome Measure
Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sarah Church
Investigator Email
sarah.church@einsteinmed.org
Investigator Phone