Clinical trial NCT03813095: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Addiction
Opioid Dependence
Opioid Withdrawal
Keywords: Addiction
Cannabis
Substance Use
Opioids: Harmful Use
Cocaine
Neurotransmitter Uptake Inhibitors
Analgesics
Mental Disorders
Narcotics
Cannabidiol
Lead sponsor: Aphios
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: [Safety] Incidence of Treatment Emergent Adverse Effects
timeFrame: Baseline through 30 days post final treatment dose up to day 60
measure: [Tolerability] Pharmacokinetics of APH-1501
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post administered dose
measure: [Tolerability] Pharmacokinetics of APH-1501
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.
measure: [Tolerability] Pharmacokinetics of APH-1501
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes post first administered dose.
Secondary outcomes:
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Vital signs
timeFrame: Day 7,14,21,28 and 60 for followup.
measure: Anxiety
timeFrame: Baseline, weeks 1-4 and 1 week post final dose.
measure: Changes in levels of physiological stress
timeFrame: Baseline through 30 days post final treatment dose up to day 60
measure: Visual Analog Scale for Craving
timeFrame: Baseline, weeks 1-4 and 30 days post final treatment up to day 60
measure: Clinical Opiate Withdrawal Scale ( COWS)
timeFrame: Baseline, weeks 1-4 adn 30 days post final treatment up to day 60
Other outcomes:
Locations:
Study officials:
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