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A Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-dependent Recreational Opioid Users.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03802227
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:
The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-dependent recreational opioid users. This study will last about 88 days for each participant.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: NKTR-181 Drug: Oxycodone IR Phase 1

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 meeting all criteria for enrollment, on Day -1 subjects will enter the clinical research study unit (CRSU) for a 2-day confinement. On Day 1, subjects will undergo a baseline MRI and will then be randomized to NKTR-181 or oxycodone immediate release (IR). Once randomized, subjects will receive a single dose of study drug (NKTR-181 or oxycodone IR) and matched alternate-treatment placebo. Subjects will undergo a series of four fMRIs (functional magnetic resonance imaging) post dose (at hours 1, 2, 4, and 8). Pre-dose and at post-dose hours 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24, pupillometry will be performed and PK blood samples will be drawn. On Day 2, subjects will be discharged from the CRSU. Following a 14- to 17-day safety follow-up period, subjects will return to the research facility clinic for the End of Study (EOS) visit (Day 16-19).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, double-dummy, parallel-group, randomized, positive control study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-dependent Recreational Opioid Users
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : April 26, 2019
Estimated Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Group 1
NKTR-181 400 mg and oxycodone IR placebo
Drug: NKTR-181
A combination of NKTR-181 and oxycodone IR placebo

Experimental: Group 2
Oxycodone IR 40 mg and NKTR-181 placebo
Drug: Oxycodone IR
A combination of oxycodone IR and NKTR-181 placebo

Primary Outcome Measures :
  1. Functional MRI BOLD signal in brain following NKTR-181 administration [ Time Frame: 8 hour period following dose administration Day 1 to 2 ]

Secondary Outcome Measures :
  1. Change in pupil diameter via pupillometry [ Time Frame: Day 1 to 19 ]
  2. PK parameters [ex: maximum plasma drug concentration (Cmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  3. PK parameters [ex: time to maximum concentration (Tmax)] [ Time Frame: 24 hour period following dose administration Day 1 to 2 ]
  4. Number of subjects with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to 19 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Key Inclusion Criteria:

  • Healthy male and female recreational opioid users. A recreational opioid user is defined as one who is not currently physically dependent on opioids but has experience in the use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 8 weeks prior to the Screening visit.
  • Have at least one urine drug screen positive for opioids other than methadone or buprenorphine during Screening to confirm recreational opioid use.

Key Exclusion Criteria:

  • Any metal fragments or other bodily metal (e.g., pacemaker, hip replacement) that would pose a risk to subjects during MRI scanning as determined by the MRI technologist and/or MRI physicist
  • History of clinically significant acute asthma or other obstructive airway disease (e.g., chronic obstructive pulmonary disease) requiring daily controller medication (e.g., inhaled corticosteroids or bronchodilators) or any condition that may increase the risk for respiratory depression (e.g., sleep apnea), judged as clinically significant by the Investigator.
  • Current neurologic conditions such as convulsive disorders, or history of severe head injury, judged as clinically significant by the Investigator.
  • Any current DSM-5 axis I psychiatric disorder, including but not limited to bipolar disorder, major depressive disorder, attention deficit hyperactivity disorder, or schizophrenia, or a neurological disorder requiring ongoing treatment.
  • History or presence of drug or alcohol dependence (except nicotine or caffeine) as defined by the Diagnostic and Statistical Manual of Mental Disorders 4th edition - Text Revision (DSM-IV-TR), including subjects who have ever been in a drug rehabilitation program (other than for treatment for smoking cessation).
  • History of claustrophobia or any other psychiatric disorder that would preclude subject tolerance of MRI procedures.
  • Current suicidal or homicidal ideation or a suicide attempt within the past 6 months.
  • Inability to commit to abstinence from use of any tobacco- or nicotine-containing products during the period from admission to discharge from the CSU, despite being administered a nicotine transdermal patch while confined in the CSU and while in the Research Clinic for MRI scans.
  • Known contraindication, sensitivity (including nausea and/or vomiting), or allergy to any opioid analgesic.
  • Current use of any medication that could affect central nervous system blood flow (e.g. certain cardiovascular medications, triptan migraine medications), unless approved by the Investigator.
  • 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 during screening or prior to the first scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03802227

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Contact: Nektar Recruitment 855-482-8676

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United States, Virginia
Investigator Site - Richmond Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Nektar Therapeutics

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Responsible Party: Nektar Therapeutics Identifier: NCT03802227     History of Changes
Other Study ID Numbers: 18-181-26
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents