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)
- Conditions
- Opioid Use Disorder
- Interventions
- Drug: NTX/BUPDrug: PBO-N/PBO-BDrug: NTX/PBO-B
- Registration Number
- NCT02537574
- Lead Sponsor
- Alkermes, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NTX/BUP NTX/BUP Oral naltrexone + sublingual buprenorphine PBO-N/PBO-B PBO-N/PBO-B Oral placebo naltrexone + sublingual placebo buprenorphine NTX/PBO-B NTX/PBO-B Oral naltrexone + sublingual placebo
- Primary Outcome Measures
Name Time Method Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection 1 week 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).
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Effects Up to 92 days The number of subjects who experienced treatment-emergent Adverse Events.
Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection 1 week 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.
Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7) 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.
Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection 1 week 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.
Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection 1 week 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.
Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection The SOWS was administered 4-6 times per day during the Treatment Period 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.
Trial Locations
- Locations (20)
TRY Research
🇺🇸Maitland, Florida, United States
CNS Healthcare
🇺🇸Orlando, Florida, United States
University Of Pennsylvania - Treatment Research Center
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
NRC Research Institute
🇺🇸Orange, California, United States
Atlantic Shores Hospital
🇺🇸Lauderhill, Florida, United States
North Country Clinical Research
🇺🇸Oceanside, California, United States
Research Centers of America
🇺🇸Oakland Park, Florida, United States
Neuroscience Research Institute
🇺🇸Winfield, Illinois, United States
John Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
PRA Health Sciences
🇺🇸Marlton, New Jersey, United States
New York State Psychiatric Institute/ Columbia University
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Midwest Clinical Research Center, LLC
🇺🇸Dayton, Ohio, United States
Western Psychiatric Institute and Clinic of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Insite Clinical Research
🇺🇸DeSoto, Texas, United States
Pharmaceutical Research Associates Inc.
🇺🇸Salt Lake City, Utah, United States