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

NCT03813095 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: APH-1501
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Addiction; Opioid Dependence; Opioid Withdrawal

Keywords

Addiction; Cannabis; Substance Use; Opioids: Harmful Use; Cocaine; Neurotransmitter Uptake Inhibitors; Analgesics; Mental Disorders; Narcotics; Cannabidiol

Outcome Measures

Primary Outcomes (4)

• [Safety] Incidence of Treatment Emergent Adverse Effects

  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.

  Baseline through 30 days post final treatment dose up to day 60

• [Tolerability] Pharmacokinetics of APH-1501

  Blood draws to determine the cannabidiol peak plasma concentration (Cmax).

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post administered dose

• [Tolerability] Pharmacokinetics of APH-1501

  Blood draws to determine the cannabidiol time to reach peak serum concentration (Tmax).

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.

• [Tolerability] Pharmacokinetics of APH-1501

  Blood draws to determine the cannabidiol time to derermine serum half life (1/2).

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.

Secondary Outcomes (16)

• Vital signs

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.

• Vital signs

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.

• Vital signs

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.

• Vital signs

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.

• Vital signs

  Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.

Study Arms (4)

APH-1501 400mg

EXPERIMENTAL

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

APH-1501 600mg

EXPERIMENTAL

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

APH-1501 800mg

EXPERIMENTAL

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

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Nano-encapsulated for oral delivery. The study is planned for patients to receive a placebo dose BID ( twice daily) for 28 days.

Drug: Placebo

Interventions

APH-1501 DRUG

The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.

APH-1501 400mg; APH-1501 600mg; APH-1501 800mg

Placebo DRUG

The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff;
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
• 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.

Sponsors & Collaborators

• Aphios: lead

MeSH Terms

Conditions

Behavior, Addictive; Opioid-Related Disorders; Marijuana Abuse; Substance-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Narcotic-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Trevor P Castor

CONTACT

7819326933; tcastor@aphios.com

Judith Castor

CONTACT

7819326933; jlpcastor@aphios.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 23, 2019
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share