Status:
TERMINATED
A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.
Lead Sponsor:
Nektar Therapeutics
Conditions:
Moderate to Severe Chronic Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-physically dependent recreational opioid users. This study will last about 88 days for each parti...
Detailed Description
This study is a single-center study in which approximately 24 subjects will be randomized to one of two treatment groups. Subjects will enter a screening period between Day -28 and Day -2. Upon meetin...
Eligibility Criteria
Inclusion
- Key
- Healthy male and female recreational opioid users, 18-65 years of age inclusive.
- Body Mass Index (BMI) between 19.0 to 45.0kg/m2
- Have at least one urine drug screen positive for opioids during Screening to confirm recreational opioid use. Subjects testing positive for methadone or buprenorphine prescribed for treatment will be excluded.
- Subjects must agree to practice adequate contraception as outlined in the protocol.
- Key
Exclusion
- Any metal fragments or other bodily metal that would pose a risk to subjects during MRI scanning as determined by the MRI technologist and/or MRI physicist
- Any clinically significant disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, or gastrointestinal systems or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk
- History of clinically significant acute asthma or other obstructive airway disease requiring daily controller medication or any condition that may increase the risk for respiratory depression
- Current neurologic conditions such as convulsive disorders, or history of severe head injury.
- Any current DSM-5 axis I psychiatric disorder or neurological disorder requiring ongoing treatment
- Current substance use disorder (moderate to severe), other than Opioid, Nicotine, THC (tetrahydrocannabinol), cocaine, or caffeine as defined by DSM-5
- Physical dependence of opioids
- History of claustrophobia or any other psychiatric disorder that would preclude subject tolerance of MRI procedures.
- Current use of any medication that could affect central nervous system blood flow (e.g. certain cardiovascular medications, triptan migraine medications)
- Clinical Opiate Withdrawal Scale (COWS) score of greater than 5 during screening or prior to first scan.
- Positive urine drug screen for buprenorphine or methadone immediately prior to the first scan.
Key Trial Info
Start Date :
October 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03802227
Start Date
October 22 2018
End Date
January 3 2020
Last Update
July 8 2021
Active Locations (1)
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1
Investigator Site - Richmond
Richmond, Virginia, United States, 23298