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

Primary Purpose

Addiction, Opioid Dependence, Opioid Withdrawal

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

APH-1501

Placebo

About this trial

This is an interventional treatment trial for Addiction focused on measuring Addiction, Cannabis, Substance Use, Opioids: Harmful Use, Cocaine, Neurotransmitter Uptake Inhibitors, Analgesics, Mental Disorders, Narcotics, Cannabidiol

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

APH-1501 400mg

APH-1501 600mg

APH-1501 800mg

Placebo Comparator: Placebo

Arm Description

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 400mg BID( twice daily) for 28 days.

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 600mg BID ( twice daily) for 28 days.

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 800mg BID ( twice daily) for 28 days.

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

Outcomes

Primary Outcome Measures

[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.

[Tolerability] Pharmacokinetics of APH-1501

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

[Tolerability] Pharmacokinetics of APH-1501

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

[Tolerability] Pharmacokinetics of APH-1501

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

Secondary Outcome Measures

Vital signs

Change in Blood pressure - diastolic & systolic (in mmHg).

Vital signs

Change in Heart Rate( beats per minute).

Vital signs

Change in Respiratory (in breaths per minute).

Vital signs

Change in Temp ( in degrees Farenheit).

Vital signs

Change in O2 saturation.

Vital signs

Change in Electrocardiogram (ECG). ( P Wave and QRS Complex)

Vital signs

Change in Blood pressure(in mmHg) diastolic and Systolic.

Vital signs

Change in Heart Rate( beats per minute).

Vital signs

Change in Respiratory (in breaths per minute).

Vital signs

Change in Temp ( in degrees Farenheit).

Vital signs

Change in O2 saturation.

Vital signs

Change in Electrocardiogram ( EKG) P Wave and QRS Complex

Anxiety

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

Changes in levels of physiological stress

Measure salivary cortisol levels

Visual Analog Scale for Craving

Changes and potential variations in cue-induced craving will be monitored and measured.

Clinical Opiate Withdrawal Scale ( COWS)

Changes and variations in common signs and symptoms of opiate withdrawal will be measured and monitor over time.

Full Information

NCT ID

NCT03813095

First Posted

January 14, 2019

Last Updated

July 26, 2021

Sponsor

Aphios

1. Study Identification

Unique Protocol Identification Number

NCT03813095

Brief Title

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

Official Title

Nanoencapsulated Cannabidiol Time Released Capsules Targeted to Reduce Cravings in the Treatment of Opioid Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aphios

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Addiction, Opioid Dependence, Opioid Withdrawal

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Triple Blind

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

APH-1501 400mg

Arm Type

Experimental

Arm Description

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 400mg BID( twice daily) for 28 days.

Arm Title

APH-1501 600mg

Arm Type

Experimental

Arm Description

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 600mg BID ( twice daily) for 28 days.

Arm Title

APH-1501 800mg

Arm Type

Experimental

Arm Description

Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 800mg BID ( twice daily) for 28 days.

Arm Title

Placebo Comparator: Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

APH-1501

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

[Safety] Incidence of Treatment Emergent Adverse Effects

Description

Time Frame

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

Title

[Tolerability] Pharmacokinetics of APH-1501

Description

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

Time Frame

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

Title

[Tolerability] Pharmacokinetics of APH-1501

Description

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

Time Frame

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

Title

[Tolerability] Pharmacokinetics of APH-1501

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Vital signs

Description

Change in Blood pressure - diastolic & systolic (in mmHg).

Time Frame

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

Title

Vital signs

Description

Change in Heart Rate( beats per minute).

Time Frame

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

Title

Vital signs

Description

Change in Respiratory (in breaths per minute).

Time Frame

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

Title

Vital signs

Description

Change in Temp ( in degrees Farenheit).

Time Frame

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

Title

Vital signs

Description

Change in O2 saturation.

Time Frame

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

Title

Vital signs

Description

Change in Electrocardiogram (ECG). ( P Wave and QRS Complex)

Time Frame

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

Title

Vital signs

Description

Change in Blood pressure(in mmHg) diastolic and Systolic.

Time Frame