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Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons (GM0020)

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.
 
ClinicalTrials.gov Identifier: NCT05382091
Recruitment Status : Not yet recruiting
First Posted : May 19, 2022
Last Update Posted : August 3, 2022
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Columbia University
The Emmes Company, LLC
University at Buffalo
Information provided by (Responsible Party):
Go Medical Industries Pty Ltd

Tracking Information
First Submitted Date  ICMJE May 16, 2022
First Posted Date  ICMJE May 19, 2022
Last Update Posted Date August 3, 2022
Estimated Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Treatment Emergent Adverse Events (TEAEs) [ Time Frame: time from from placement of first implant set until immediately before placement of the second implant set (or 24 weeks after first implant set) ]
    Incidence and Severity of TEAEs
  • Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 24 weeks after second implant set ]
    Incidence and Severity of TEAEs
  • Treatment Emergent Adverse Events (TEAEs) [ Time Frame: through Week 48 ]
    Incidence and Severity of TEAEs
  • Adverse Events of Special Interest (AESI) [ Time Frame: time from from placement of first implant set until immediately before placement of the second implant set (or 24 weeks after first implant set) ]
    Incidence of AESIs related to the surgical procedure and local reaction to the implant over time
  • Adverse Events of Special Interest (AESI) [ Time Frame: 24 weeks after second implant set ]
    Incidence of AESIs related to the surgical procedure and local reaction to the implant over time
  • Adverse Events of Special Interest (AESI) [ Time Frame: through Week 48 ]
    Incidence of AESIs related to the surgical procedure and local reaction to the implant over time
  • Deaths [ Time Frame: through Week 48 ]
    Incidence of study deaths
  • Serious Adverse Events (SAEs) [ Time Frame: time from from placement of first implant set until immediately before placement of the second implant set (or 24 weeks after first implant set) ]
    Incidence of SAEs
  • Serious Adverse Events (SAEs) [ Time Frame: 24 weeks after second implant set ]
    Incidence of SAEs
  • Serious Adverse Events (SAEs) [ Time Frame: through Week 48 ]
    Incidence of SAEs
  • Adverse events (AEs) causing study discontinuation [ Time Frame: through Week 48 ]
    AEs that lead to study discontinuation
  • Opioid overdose events [ Time Frame: time from placement of first implant set until immediately before placement of the second implant set (or 24 weeks after first implant set) ]
    Incidence of opioid overdose events
  • Opioid overdose events [ Time Frame: 24 weeks after second implant set ]
    Incidence of opioid overdose events
  • Opioid overdose events [ Time Frame: through Week 48 ]
    Incidence of opioid overdose events
  • Laboratory abnormalities [ Time Frame: through Week 48 ]
    Incidence and Severity of lab abnormalities
  • Suicidality [ Time Frame: through Week 48 ]
    incidence of suicidal ideation and suicidal behavior captured with the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Concomitant medications [ Time Frame: through Week 48 ]
    Proportion of participants who initiate concomitant medications
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2022)
  • AUC0-t of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
  • AUC0-t of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
  • AUC0-infinity of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
  • AUC0-infinity of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
  • Cmax of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
  • Cmax of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the plasma 6-beta-naltrexol concentration (Cmax) after dosing on Day 1
  • Tmax of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
  • Tmax of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
  • Proportion of participants that maintain a minimum plasma concentration (13 weeks) [ Time Frame: up to Week 48 ]
    Proportion of participants who maintain NTX blood levels of ≥2 ng/mL for ≥13 weeks
  • Proportion of participants that maintain a minimum plasma concentration (24 weeks) [ Time Frame: up to Week 48 ]
    Proportion of participants who maintain NTX blood levels of ≥2 ng/mL for ≥24 weeks
  • Abstinence from drugs of abuse by UDS [ Time Frame: pre-dose (prior to each implant procedure), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
  • Abstinence from drugs of abuse by Timeline Followback (TLFB) [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
  • Abstinence from alcohol [ Time Frame: pre-dose (prior to each implant procedure), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from alcohol as measured using and alcohol breathalyzer
  • Opioid craving (VAS) [ Time Frame: Baseline, pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    The craving for opioids will be measured using a horizontal visual analog scale (VAS), which ranges from 0 (no craving) to 10 (most intense craving possible).
  • Opioid withdrawal (SOWS) [ Time Frame: pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    The SOWS is a 16-item questionnaire designed to measure the severity of opioid withdrawal symptoms. The participant rates the intensity of symptoms using a 5-point scale; with 0 representing "not at all" and 4 representing "extremely".
  • Opioid withdrawal (COWS) [ Time Frame: pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    The COWS is a questionnaire designed to measure 11 common opioid withdrawal signs and symptoms. The summed score provides information about the severity of opioid withdrawal and the level of physical dependence on opioids. Total scores range from 0 to 47, and withdrawal is classified as mild (5-12), moderate (13-24), moderately severe (25-36), or severe (>36)
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Assessment of Depression/Mood via the HDRS, is a clinician-administered instrument, useful for following both depression and suicidal ideation, and for following typical symptoms of subacute withdrawal (e.g., low appetite, fatigue, poor sleep). A score of 1 or more to item 3 (suicidality) prompts a clinician assessment for suicide risk before leaving the clinic.
  • Brief Symptom Inventory 18 (BSI-18) [ Time Frame: Baseline, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Assessment of Depression/Mood via the BSI-18; comprising 18 items (ranging from 0 = not at all to 4 = extremely), assesses psychiatric symptoms in three distinct domains: depression, anxiety, and somatization. The total score ranges from 0 to 72 with higher scores indicating higher symptom severity.
  • Quality of Life Score (QoL) [ Time Frame: Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Quality of life as measured through Quality of Life Enjoyment and Satisfaction Questionnaire (short form). is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). If items are left blank the maximum and minimum scores must be modified to reflect the number of items scored.
  • Treatment Satisfaction (TSQM-14) [ Time Frame: Before second implant and Week 37 to 48 ]
    The TSQM-14 is comprised of 14 questions that provide scores on four scales: effectiveness (3 items), side effects (5 items), convenience (3 items) and global satisfaction (3 items). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • AUC0-t of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
  • AUC0-t of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve from 0 to the time of last measurable concentration (AUC0-t)
  • AUC0-infinity of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
  • AUC0-infinity of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    area under the plasma concentration-time curve extrapolated to infinity (AUC0-infinity)
  • Cmax of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
  • Cmax of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the plasma 6-beta-naltrexol concentration (Cmax) after dosing on Day 1
  • Tmax of naltrexone [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
  • Tmax of 6-beta-naltrexol [ Time Frame: collected before each implant administration (pre-dose), and 3 hours, 7 days, 14 days, 28 days, then every 14 days after implant administration until second implant procedure or Week 24 ]
    Single-dose PK measurement of the time to reach the maximum plasma naltrexone concentration (Tmax) after dosing on Day 1
  • Proportion of participants that maintain a minimum plasma concentration (13 weeks) [ Time Frame: up to Week 48 ]
    Proportion of participants who maintain NTX blood levels of ≥2 ng/mL for ≥13 weeks
  • Proportion of participants that maintain a minimum plasma concentration (24 weeks) [ Time Frame: up to Week 48 ]
    Proportion of participants who maintain NTX blood levels of ≥2 ng/mL for ≥24 weeks
  • Abstinence from drugs of abuse by UDS [ Time Frame: pre-dose (prior to each implant procedure), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
  • Abstinence from drugs of abuse by Timeline Followback (TLFB) [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS)
  • Abstinence from alcohol [ Time Frame: pre-dose (prior to each implant procedure), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Proportion of participants who maintain abstinence from alcohol as measured using and alcohol breathalyzer
  • Opioid craving [ Time Frame: Baseline, pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Opioid craving as measured by the Visual Analog Craving Scales (VAS)
  • Opioid withdrawal (SOWS) [ Time Frame: pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Opioid withdrawal as measured with the Subjective Opiate Withdrawal Scale (SOWS)
  • Opioid withdrawal (COWS) [ Time Frame: pre-dose prior to implant (Day 0), Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Opioid withdrawal as measured with the Clinical Opiate Withdrawal Scale (SOWS)
  • Depression/Mood [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Mood as measured through the Hamilton Depression Rating Scale (HDRS)
  • Depression/Mood [ Time Frame: Baseline, Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Mood as measured through the Brief Symptom Inventory (BSI)
  • Quality of Life Score [ Time Frame: Day 28, Day 42, Day 56, then every 28 days until second implant procedure or Week 48 ]
    Quality of life as measured through Quality of Life scale (QoL)
  • Treatment Satisfaction [ Time Frame: Before second implant and Week 37 to 48 ]
    Treatment satisfaction recorded on the Treatment Satisfaction Questionnaire for Medication (TSMQ-14)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
Official Title  ICMJE A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing
Brief Summary This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered a second set of implants after 13-24 weeks.
Detailed Description

This is a Phase II, multi-center, open-label study designed to evaluate the safety profile and the efficacy of the OLANI when used in participants who meet the diagnosis of opioid use disorder (OUD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and who will be voluntarily seeking relapse-prevention treatment using the naltrexone (NTX) implant.

Participants eligible for the study have diagnosed OUD, have completed withdrawal from opioids, and are no longer physically dependent at the time of study enrollment. After completing the informed consent process for the study, all participants will receive their initial OLANI set (two implants) implanted subcutaneously by a study surgeon and will be followed by a medical and surgical research team, receiving medical management intervention and blood draws to measure levels of NTX and its metabolite, 6-beta-naltrexol (6BN). For interested participants, a second implant set will be offered, with placement 13-24 weeks after the initial procedure, after which all participants will be followed for an additional 24 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Use Disorder
Intervention  ICMJE Drug: naltrexone implant
3.6 g per implant set each containing 60% naltrexone
Other Names:
  • OLANI
  • O'Neil Long Acting Naltrexone Implant
Study Arms  ICMJE Experimental: OLANI (naltrexone implant)
2 OLANI implants containing 60% naltrexone (3.6 g total NXT) administered at Day 0 with repeat dosing at Week 13 to 24
Intervention: Drug: naltrexone implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2022)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women between 18 and 65 (inclusive) years old
  • Meet criteria for a current (within the previous 12-months) DSM-5 diagnosis of OUD at screening, and voluntarily seeking relapse-prevention treatment with NTX implant
  • Completed opioid withdrawal as demonstrated by a negative naloxone challenge test (i.e., has tolerated naloxone 0.8 mg)
  • Individuals currently treated with NTX will be eligible to receive the implant at the end of the dosing interval of either Vivitrol or oral NTX
  • Have no medical or psychiatric contraindications to treatment either with NTX or with the OLANI, as determined by the site clinician and based on medical history and current health status
  • Able to sufficiently speak and understand English and understand study procedures
  • Able and willing to provide written informed consent
  • Able and willing to provide detailed contact information for both self and for close contact(s) on the locator form
  • Able and willing to comply with the requirements and procedures of the protocol, including tolerating a minor surgical procedure with local anesthetic for placement of the implant sets into the subcutaneous tissue of the abdomen
  • Have an initial weight between 45.3 and 130 kg (inclusive) or have a BMI of 18.5 to 35.0 (inclusive)
  • For female participants of childbearing potential, a willingness to practice an effective method of birth control for the duration of participation in the study. Acceptable methods of birth control are specified on the data collection form and in the Manual of Procedures (MOP), and methods other than those specified are not permitted, except in combination with a study-acceptable method; and willingness to complete urine pregnancy testing to confirm non-pregnant status, as per the study schedule and as requested by the site clinician.

Exclusion Criteria:

  • Has a condition, disease state, previous medical history, or observed abnormality(ies) (including physical examination, electrocardiogram [ECG], laboratory evaluation, or urinalysis finding) identified during screening that, in the opinion of the site clinician, would preclude safe participation in the study, would affect the ability of the participant to adhere to the protocol, or would interfere with the study assessments, including, but not limited to the following:

    • A significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable using protocol-allowed medication(s) for the 30 days immediately preceding the proposed administration of OLANI
    • Has had significant suicidal ideation or behavior within the past year
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value more than three times the upper limit of normal, or a different indicator of clinically significant liver cirrhosis (e.g., bilirubin and albumin will also be assessed)
    • Has a condition (e.g., chronic pain) that requires ongoing treatment with opiate based medication
    • Has any contraindicated medical condition per the approved labelling for NTX containing products
  • Has physiological dependence on alcohol and/or sedative-hypnotics that require medical detoxification
  • If female, is currently pregnant or breastfeeding, is planning to conceive during the period of study engagement, has a positive blood pregnancy test, or is unwilling to practice effective contraception during study participation
  • Has a known hypersensitivity to NTX
  • Is not able to provide blood samples due to extensive vein damage
  • Has a known hypersensitivity to polylactic acid based materials, including disposable sutures or implants
  • Has a known hypersensitivity to local anesthesia
  • Is prone to skin rashes, skin irritation, or has a diagnosed or observed skin condition (e.g., recurrent eczema)
  • Is tattooed in the proposed implantation area or demonstrates any abnormal skin tissue in the proposed implantation area
  • Currently confined or detained in a penal institution or sentenced to such an institution under a criminal or civil statute or detained in other facilities by virtue of statutes.
  • Any additional condition(s) that, in the investigator's opinion, would prohibit the participant from completing the study or that would not be in the best interest of the participant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05382091
Other Study ID Numbers  ICMJE GM0020
4UH3DA047720-03 ( U.S. NIH Grant/Contract )
240359 ( Other Identifier: NIH ERA Human Subjects Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Go Medical Industries Pty Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Go Medical Industries Pty Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • New York State Psychiatric Institute
  • Columbia University
  • The Emmes Company, LLC
  • University at Buffalo
Investigators  ICMJE
Principal Investigator: Adam Bisaga, MD New York State Psychiatric Institute
PRS Account Go Medical Industries Pty Ltd
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP