AddictionPhase 2NCT03813095
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
A Phase 2 study testing APH-1501 in people with Addiction and Opioid Dependence, run by Aphios.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Addiction, Opioid Dependence, Opioid Withdrawal
- What is being tested?
- APH-1501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nanoencapsulated Cannabidiol Time Released Capsules Targeted to Reduce Cravings in the Treatment of Opioid Addiction
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.
Read the 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.
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Being tested
- APH-1501, Placebo
- Keywords
- Addiction, Cannabis, Substance Use, Opioids: Harmful Use, Cocaine, Neurotransmitter Uptake Inhibitors, Analgesics, Mental Disorders, Narcotics, Cannabidiol
- Medical subject headings
- Behavior, Addictive, Opioid-Related Disorders, Marijuana Abuse, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APH-1501Drug
The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.
PlaceboDrug
The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Change in Blood pressure - diastolic \& systolic (in mmHg).
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in Heart Rate( beats per minute).
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in Respiratory (in breaths per minute).
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in Temp ( in degrees Farenheit).
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in O2 saturation.
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in Electrocardiogram (ECG). ( P Wave and QRS Complex)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes 240 minutes, 480 minutes, post first administered dose.
Vital signs
Change in Blood pressure(in mmHg) diastolic and Systolic.
Measured: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Heart Rate( beats per minute).
Measured: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Respiratory (in breaths per minute).
Measured: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Temp ( in degrees Farenheit).
Measured: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in O2 saturation.
Measured: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Electrocardiogram ( EKG) P Wave and QRS Complex
Measured: Day 7,14,21,28 and 60 for followup.
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
Measured: Baseline, weeks 1-4 and 1 week post final dose.
Changes in levels of physiological stress
Measure salivary cortisol levels
Measured: Baseline through 30 days post final treatment dose up to day 60
Visual Analog Scale for Craving
Changes and potential variations in cue-induced craving will be monitored and measured.
Measured: Baseline, weeks 1-4 and 30 days post final treatment up to day 60
Clinical Opiate Withdrawal Scale ( COWS)
Changes and variations in common signs and symptoms of opiate withdrawal will be measured and monitor over time.
Measured: Baseline, weeks 1-4 adn 30 days post final treatment up to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startOct 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aphios
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813095
- Sponsor's protocol ID
- APH-1501
- Status last verified
- Jul 2021
- First submitted
- 14 Jan 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoencapsulated Cannabidiol Time Released Capsules Targeted to Reduce Cravings in the Treatment of Opioid Addiction
- ClinicalTrials.gov ID
- NCT03813095
- Acronym / sponsor ID
- APH-1501
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Keywords
- Addiction, Cannabis, Substance Use, Opioids: Harmful Use, Cocaine, Neurotransmitter Uptake Inhibitors, Analgesics, Mental Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- AphiosIndustry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| APH-1501 400mg | Experimental | Drug: APH-1501Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 400mg BID( twice daily) for 28 days. |
| APH-1501 600mg | Experimental | Drug: APH-1501Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 600mg BID ( twice daily) for 28 days. |
| APH-1501 800mg | Experimental | Drug: APH-1501Nano-encapsulated for oral delivery. The study is planned for patients to receive APH 1501 800mg BID ( twice daily) for 28 days. |
| Placebo Comparator: Placebo | Placebo comparator | Drug: PlaceboNano-encapsulated for oral delivery. The study is planned for patients to receive a placebo dose BID ( twice daily) for 28 days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APH-1501The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration. | Drug | APH-1501 400mg, APH-1501 600mg, APH-1501 800mg |
| PlaceboThe placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product. | Drug | Placebo Comparator: Placebo |
Primary outcome
[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.
[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).
[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).
[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).
16 secondary outcomes
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.
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.
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.
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.
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.
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.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Time frame: Day 7,14,21,28 and 60 for followup.
Anxiety
Time frame: Baseline, weeks 1-4 and 1 week post final dose.
Changes in levels of physiological stress
Time frame: Baseline through 30 days post final treatment dose up to day 60
Visual Analog Scale for Craving
Time frame: Baseline, weeks 1-4 and 30 days post final treatment up to day 60
Clinical Opiate Withdrawal Scale ( COWS)
Time frame: Baseline, weeks 1-4 adn 30 days post final treatment up to day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Addiction
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Not yet recruitingObservational study
Attachment and Prognostic Factor: the Implicit Approach
Dependence Addictive
Recruiting
Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
Substance Use Disorder (SUD)
Recruiting
Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project
Addiction
Not yet recruiting
Evaluation of Interventions to Promote Work-Life Balance Among Students at Gaming Schools
Internet Gaming Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APH-1501 in people with Addiction and Opioid Dependence, run by Aphios.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trevor P Castor (7819326933, tcastor@aphios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Safety] Incidence of Treatment Emergent Adverse Effects (time frame: Baseline through 30 days post final treatment dose up to day 60). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.