A Phase 2 interventional study of APH-1501 and Placebo in Addiction, Opioid Dependence and Opioid Withdrawal, sponsored by Aphios. Not yet recruiting. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Aphios · Phase 2, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 32 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Aphios is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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
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
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
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 investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.
The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.
[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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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.
Vital signs
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.
Vital signs
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.
Vital signs
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.
Vital signs
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.
Vital signs
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.
Vital signs
Change in Blood pressure(in mmHg) diastolic and Systolic.
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Heart Rate( beats per minute).
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Respiratory (in breaths per minute).
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Temp ( in degrees Farenheit).
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in O2 saturation.
Time frame: Day 7,14,21,28 and 60 for followup.
Vital signs
Change in Electrocardiogram ( EKG) P Wave and QRS Complex
Time frame: 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
Time frame: Baseline, weeks 1-4 and 1 week post final dose.
Changes in levels of physiological stress
Measure salivary cortisol levels
Time frame: 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.
Time frame: 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.
Time frame: Baseline, weeks 1-4 adn 30 days post final treatment up to day 60
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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