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Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction

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ClinicalTrials.gov Identifier: NCT03813095
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Aphios

Brief Summary:
The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.

Condition or disease Intervention/treatment Phase
Addiction Opioid Dependence Opioid Withdrawal Drug: APH-1501 Drug: Placebo Phase 2

Detailed Description:

This is a Phase 2a Exploratory Pilot study assessing the efficacy, immunogenicity and pharmacology of APH-1501, Cannabidiol (CBD), a unique, bioactive component of marijuana, in reducing early attrition and improving outcome in opioid-dependent individual in adults diagnosed with an opioid addiction, ages 21-55 years of age. Subjects will be randomized into 4 groups receiving APH-1501 or placebo over a 30 day period that includes a regimen of reformulated 400, 600 or 800 mg/m2 APH 1501 or placebo. This trial will target opioid-dependent patients who have completed detoxification and are in a treatment facility. During the trial period, participants will be given APH-1501 twice a day for 30 days. Given prior evidence based research on CBD there should be minimum to no side effects to taking APH 1501. The overarching research question for the study is the efficacy of APH 1501, pharmaceutical-grade CBD (>98.5% and < 0.3% Δ9-THC) for clinical use in the treatment of opioid addiction.

This is an intervention model design with three treatment groups, parallel assignment. This study is designed for sufficient time in between dose escalations to allow for interim analysis of safety and tolerability data to be considered for the safest approach to assess the effects of the compound as a therapeutic agent. Randomization will be stratified by the Diagnostic and Statistical Manual (DSM)_V diagnosis taking into account any co-morbid features or dual diagnosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple Blind
Primary Purpose: Treatment
Official Title: Nanoencapsulated Cannabidiol Time Released Capsules Targeted to Reduce Cravings in the Treatment of Opioid Addiction
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APH-1501 400mg
Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 400mg BID( twice daily) for 28 days.
Drug: APH-1501
The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.

Experimental: APH-1501 600mg
Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 600mg BID ( twice daily) for 28 days.
Drug: APH-1501
The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.

Experimental: APH-1501 800mg
Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 800mg BID ( twice daily) for 28 days.
Drug: APH-1501
The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.

Placebo Comparator: Placebo Comparator: Placebo
Nano-encapsulated for oral delivery. The study is planned for patients to receive a placebo dose BID ( twice daily) for 28 days.
Drug: Placebo
The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.




Primary Outcome Measures :
  1. [Safety] Incidence of Treatment Emergent Adverse Effects [ Time Frame: Baseline through 30 days post final treatment dose up to day 60 ]

    Number of patients experiencing treatment emergent Adverse Effects(AE's) and Serious Adverse effects(SAE's) during treatment and follow-up. Patients will be asked to complete the Systematic Assessment for Treatment Emergent Events (SAFTEE)

    The SAFTEE is a questionnaire that rates the current severity of a wide range of somatic, behavioral and affective symptoms in general and specific inquiry formats. It is designed to report adverse health events. Contains ~ 25 detailed questions that systematically address 29 body systems. Responses are rated on five levels of severity.


  2. [Tolerability] Pharmacokinetics of APH-1501 [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post administered dose ]
    Blood draws to determine the cannabidiol peak plasma concentration (Cmax).

  3. [Tolerability] Pharmacokinetics of APH-1501 [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose. ]
    Blood draws to determine the cannabidiol time to reach peak serum concentration (Tmax).

  4. [Tolerability] Pharmacokinetics of APH-1501 [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose. ]
    Blood draws to determine the cannabidiol time to derermine serum half life (1/2).


Secondary Outcome Measures :
  1. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in Blood pressure - diastolic & systolic (in mmHg).

  2. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in Heart Rate( beats per minute).

  3. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in Respiratory (in breaths per minute).

  4. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in Temp ( in degrees Farenheit).

  5. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in O2 saturation.

  6. Vital signs [ Time Frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose. ]
    Change in Electrocardiogram (ECG). ( P Wave and QRS Complex)

  7. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in Blood pressure(in mmHg) diastolic and Systolic.

  8. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in Heart Rate( beats per minute).

  9. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in Respiratory (in breaths per minute).

  10. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in Temp ( in degrees Farenheit).

  11. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in O2 saturation.

  12. Vital signs [ Time Frame: Day 7,14,21,28 and 60 for followup. ]
    Change in Electrocardiogram ( EKG) P Wave and QRS Complex

  13. Anxiety [ Time Frame: Baseline, weeks 1-4 and 1 week post final dose. ]
    Anxiety Assessment using the Beck Anxiety Inventory ( BAI) . The BAI is a self-report measure of anxiety. The total score is calculated by finding the sum of the 21 items. Score of 0-21 = low anxiety Score of 22-35 = moderate anxiety Score of 36 and above = potentially concerning levels of anxiety

  14. Changes in levels of physiological stress [ Time Frame: Baseline through 30 days post final treatment dose up to day 60 ]
    Measure salivary cortisol levels

  15. Visual Analog Scale for Craving [ Time Frame: Baseline, weeks 1-4 and 30 days post final treatment up to day 60 ]
    Changes and potential variations in cue-induced craving will be monitored and measured.

  16. Clinical Opiate Withdrawal Scale ( COWS) [ Time Frame: Baseline, weeks 1-4 adn 30 days post final treatment up to day 60 ]
    Changes and variations in common signs and symptoms of opiate withdrawal will be measured and monitor over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages Eligible for Study: 21 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Meets DSM-V criteria with a Substance Use Disorder
  • Meets protocol-specified criteria for qualification and contraception
  • Must consent to random assignment, and be willing to commit to medication ingestion.
  • Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff;
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
    3. the analysis of results
  • Individuals with clinically significant medical disorders or lab abnormalities.
  • History of cardiovascular events, head trauma or seizures
  • Use of any psychoactive drug or medication at any time of study enrollment and participation
  • Having taken any opioid medication in the last 14 days
  • Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-monoamine oxidase inhibitor (MAO-I) (antidepressants, non-benzodiazepine anxiolytics, and Attention Deficit -Hyperactivity Disorder(ADHD) medications.
  • Pregnant or breastfeeding
  • Not using appropriate contraceptive measures ( hormonal, Nuvo-ring, Depo-Provera, IUD) or other barrier protection.
  • Psychiatric condition as defined by the DSM-V - Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated Major Depressive Disorder (MDD), Dysthymia, Generalized Anxiety Disorder (GAD), Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).
  • Hypersensitivity to cannabinoids
  • Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal or homicidal risk (answers 'yes' on questions 4 or 5 of C-SSRS) will be referred for assessment by a qualified mental health professional.
  • Individuals taking an investigational agent within the last 30 days before baseline visit.

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 ClinicalTrials.gov identifier (NCT number): NCT03813095


Contacts
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Contact: Trevor P Castor 7819326933 tcastor@aphios.com
Contact: Judith Castor 7819326933 jlpcastor@aphios.com

Sponsors and Collaborators
Aphios
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Responsible Party: Aphios
ClinicalTrials.gov Identifier: NCT03813095    
Other Study ID Numbers: APH-1501
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Aphios:
Addiction
Cannabis
Substance Use
Opioids: Harmful Use
Cocaine
Neurotransmitter Uptake Inhibitors
Analgesics
Mental Disorders
Narcotics
Cannabidiol
Additional relevant MeSH terms:
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Opioid-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders