Opioid Use Disorder Clinical Trial
Official title:
A Single-Dose, Open-Label Study of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Individuals
Verified date | May 2016 |
Source | Indivior Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - If female, must be surgically sterile or two-years post-menopausal and have a negative pregnancy test. Subjects should take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice double-barrier forms of birth control from study screening through the last dose of study medication. - Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence and who are seeking opioid-dependence treatment with methadone. - Willing to cooperate with study procedures and provide written informed consent prior to start of any study procedures. - Agree not to take any buprenorphine product (other than RBP-6000) throughout their participation in the study. - Body mass index of = 18 to = 33 kg/m2. - Total bilirubin < 2.5 mg/dL (51 µmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 × the upper limit of normal (ULN), serum creatinine < 2 x ULN, or international normalized ratio (INR) = 2.0. - Normal or no clinically significant ECG findings at screening Exclusion Criteria: - Require ongoing opioid therapy for pain or other chronic medical conditions. - Additionally, individuals who answer "yes" to both of the following questions will be excluded from participation: A) Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than those kinds of pain today? B) If yes, has the pain persisted for three months or more? - Currently dependent by DSM-IV-TR criteria on any substance other than opioids, caffeine, or nicotine. - Positive urine screen at intake for barbiturates, benzodiazepines, buprenorphine, or methadone. - History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the study physician, would jeopardize the safety of the subject. - Clinically significant abnormal finding on physical exam or in medical history; serology positive for HIV, hepatitis B or C [HBV antigen S positive, acute HBsAg and IgM antiHBc Chronic HCV antibody HCV, HCV RNA- acute: HCV RNA (PCR)]. - History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, methadone, or the ATRIGEL Delivery System. - Donation of more than 250 mL of blood or plasma, or participation in another clinical trial, within 30 days prior to signing of the informed consent document for this study. - Currently (during past 30 days from the signing of the informed consent document) engaged in opioid agonist, partial agonist, or antagonist treatment, or require on-going prescription or over-the-counter medications that are clinically relevant P450 3A4 inducers or inhibitors [azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin),]. - Reporting taking buprenorphine within 30 days of screening. - Significant traumatic injury, major surgery or open biopsy within the prior 4 weeks. - Subjects who have been previously excluded from participation or previously enrolled into the study. - Subjects who are unable, in the opinion of the Principal Investigator and/or the medically responsible physician, to comply fully with the study requirements. - Subjects who have participated in another investigational product trial within 30 days of screening. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Scientific Clinical Research | Ft. Lauderdale | Florida |
Lead Sponsor | Collaborator |
---|---|
Indivior Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence. | The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment. | Day 1 to Day 85 | Yes |
Secondary | Maximum plasma concentration (Cmax) for buprenorphine and norbuprenorphine | PK samples to be collected to determine Cmax over the post-injection period | Day 1 through Day 85 | No |
Secondary | Time to occurrence of Cmax (Tmax) for buprenorphine and norbuprenorphine | PK samples to be collected to determine Tmax over the post-injection period | Day 1 through Day 85 | No |
Secondary | Area under the plasma concentration versus time curve (AUC) for buprenorphine and norbuprenorphine | AUC to be measured from time 0 to the last sampling time post-injection at which concentrations were at or above the limit of quantitation | Day 1 through Day 85 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06021431 -
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
|
N/A | |
Completed |
NCT06266572 -
Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment
|
Phase 1 | |
Recruiting |
NCT05037682 -
Pain and Opioid Management in Older Adults
|
N/A | |
Completed |
NCT06200740 -
Remotely Observed Methadone Evaluation
|
N/A | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Completed |
NCT02593474 -
Medication-Assisted Treatment for Youth With Substance Use Disorders
|
Phase 1 | |
Completed |
NCT02559973 -
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
|
Phase 1 | |
Completed |
NCT02440256 -
Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial
|
N/A | |
Completed |
NCT05587998 -
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
|
Phase 1 | |
Terminated |
NCT04577144 -
An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
|
||
Recruiting |
NCT06001437 -
Following Outcomes Remotely Within Addiction Recovery Domains
|
||
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Completed |
NCT05546229 -
Assessment of Methadone and Buprenorphine in Interstitial Fluid
|
||
Recruiting |
NCT06206291 -
Cannabidiol for Opioid Addiction
|
Phase 2 | |
Completed |
NCT05552040 -
START NOW in the Treatment of Opioid Addicted Individuals
|
N/A | |
Recruiting |
NCT05459922 -
Adjunctive Bright Light Therapy for Opioid Use Disorder
|
N/A | |
Recruiting |
NCT05343169 -
Community-based Education, Navigation, and Support Intervention for Military Veterans
|
N/A | |
Recruiting |
NCT06081985 -
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
|
N/A | |
Not yet recruiting |
NCT04231708 -
Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder
|
Phase 2 | |
Completed |
NCT03033732 -
A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
|
Phase 4 |