- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02710526
Phase II Pharmacokinetics Study of CAM2038
April 29, 2020 updated by: Braeburn Pharmaceuticals
A Phase II, Open-label, Partially Randomized, 3 Treatment Groups, Multi-Site Study Assessing Pharmacokinetics After Administration of the Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) at Different Injection Sites in Opioid-Dependent Subjects With Chronic Pain
Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.
Study Overview
Detailed Description
This is a phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038 weekly and monthly at different injection sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects with a history of chronic non cancer pain.
The study will involve three phases: Screening, Treatment, and Follow up.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35215
- Parkway Medical
-
-
New Jersey
-
Berlin, New Jersey, United States, 08009
- Hassman Research Institute
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73112
- The Rivus Wellness & Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must provide written informed consent prior to the conduct of any study related procedures.
- Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive.
- Body mass index between 19 and 35 kg/m2, inclusive.
- Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5) or past medical history of opioid use disorder currently being treated with SL BPN.
- Subject must be taking SL BPN (Subutex® equivalent) 24 mg (Group 1 and Group 2) or ≥24 mg (Group 3) daily for at least 30 days prior to Screening.
- Subject has a history of moderate to severe chronic non cancer pain.
- Male and female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening visit to Follow-up phone call).
- Subject must be willing and able to comply with all study procedures and requirements.
Exclusion Criteria:
- Individuals meeting DSM-V substance use disorder criteria for alcohol, benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse (excluding caffeine, tobacco or THC/marijuana).
- Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG; Fridericia's corrected QT interval [QTcF] ≥450 msec. for males or ≥470 msec. for females), and laboratory evaluations (including hematology, clinical chemistry, urinalysis at Screening), in the opinion of the Investigator.
- Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study, including subjects who are at a risk for gastrointestinal obstruction or paralytic ileus or who have severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors.
- Use (therapeutic or non-therapeutic) of opioids other than SL BPN.
- Aspartate aminotransferase (AST) levels > 3 X the upper limit of normal, alanine aminotransferase (ALT), levels > 3 X the upper limit of normal, total bilirubin > 1.5 X the upper limit of normal, or creatinine > 1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in study.
- Pregnant or lactating or planning to become pregnant during the study.
- Diagnosis of, or currently under investigation for, fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness.
- History of chemotherapy or confirmed malignancy (except basal cell or squamous carcinoma of the skin) within the past 2 years.
- Clinically significant history of, or current evidence for, suicidal ideation or those who are actively suicidal, as based on the Columbia-Suicide Severity Rating Scale (C-SSRS; grade 4 or 5).
- Clinically significant history of major depressive disorder that is poorly controlled with medication.
- Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038.
- Exposure to any investigational drug within the 4 weeks prior to Screening.
- Participants with a clinically significant history of risk factors of Torsades de Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy, heart failure, hypokalemia, family history of Long QT Syndrome.
- On medications that have the potential for prolonging the QT interval or who may require such medications during the course of the study along with clinically significant abnormalities on screening electrocardiogram (ECG) readings as deemed by the investigator.
- Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).
- Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff.
- Is an employee of the Investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or is a family member of an employee or of the Investigator.
- Any pending legal action that could prohibit participation or compliance in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 32 mg CAM2038 weekly
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
|
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Names:
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Experimental: 128 mg CAM2038 monthly injection
Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
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Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Names:
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Experimental: 160 mg CAM2038 monthly injection
Group 3: 24mg sublingual BPN for the first 7 days, and then 160 mg of CAM2038 subcutaneous monthly injection in the buttocks starting on Day 8.
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Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Average Steady State Concentration-Buprenorphine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Average steady state concentration-Buprenorphine-Pharmacokinetic Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Maximum Steady State Concentration-Buprenorphine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Time to Maximum Concentration at Steady State-Buprenorphine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
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Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm.
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State
Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population
|
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
|
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Average Steady State Concentration-Norbuprenorphine
Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
|
PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
|
Maximum Steady State Concentration-Norbuprenorphine
Time Frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
|
Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
|
PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
|
Time to Maximum Concentration at Steady State-Norbuprenorphine
Time Frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
|
Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population
|
PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population
|
99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of Average Daily Pain by Week (ITT Population)
Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects.
11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.
(ITT Population)
|
99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population
|
99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Subject-rated Worst Daily Pain
Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population.
11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.
|
99 days for Group 1, 162 days for Group 2, 127 days for Group 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Sullivan, Parkway Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
May 17, 2017
Study Completion (Actual)
July 3, 2017
Study Registration Dates
First Submitted
March 9, 2016
First Submitted That Met QC Criteria
March 11, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Actual)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Pain
- Neurologic Manifestations
- Narcotic-Related Disorders
- Chronic Pain
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- HS-15-549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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