AAV8-hCocH for Cocaine Use Disorder
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ClinicalTrials.gov Identifier: NCT04884594 |
Recruitment Status :
Recruiting
First Posted : May 13, 2021
Last Update Posted : November 2, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence, in Remission | Drug: AAV8-hCocH | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Intravenous Administration of AAV8-human Cocaine Hydrolase to Treat Cocaine Use Disorder |
Actual Study Start Date : | October 8, 2021 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: AAV8-hCocH Low dose: 2e12 vg/kg
Cohort 1: Participant receives one-time IV administration of low dose 2e12 vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
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Drug: AAV8-hCocH
2e12 vg/kg single infusion intravenous |
Experimental: AAV8-hCocH Medium dose: 6e12vg/kg
Cohort 2: Participant receives one-time IV administration of medium dose 6e12vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
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Drug: AAV8-hCocH
6e12vg/kg single infusion intravenous |
Experimental: AAV8-hCocH High dose: 2e13 vg/kg
Cohort 3: Participant receives one-time IV administration of high dose 2e13 vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
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Drug: AAV8-hCocH
2e13 vg/kg single infusion intravenous |
- Adverse Events [ Time Frame: 60 months ]Number of participants with treatment-related adverse events
- Change in enzyme expression profile [ Time Frame: Baseline, 24 months ]Serum level of AAV8-hCocH gene expression
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 24 months ]Cmax is measured as the peak concentration of AAV8 in the blood after intravenous infusion
- Time of peak concentration (tmax) [ Time Frame: 24 months ]The time to maximum plasma concentration of AAV8 in the blood after intravenous infusion
- Half-Life (t1/2) [ Time Frame: 24 months ]The time for plasma concentration of AAV8 in the blood to be reduced to exactly half of starting concentration
- Area under the Concentration-Time Curve (AUC) [ Time Frame: 24 months ]AUC is a measure of the AAV8 serum concentration over time. Used to characterize drug absorption.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Non-treatment seeking male or females ages 18 to 65 years, inclusive.
- DSM-5 diagnosis of cocaine use disorder in sustained remission as confirmed by the PI's review of the medical record.
- Are motivated to abstain from cocaine use during the period of the study, as evidenced both by the judgment of the Investigator or designee and by compliance with the requirement to make regular clinic visits.
- In the opinion of the PI, be in good general health as determined by medical and psychiatric history, general clinical examination, vital signs, and laboratory tests.
- Have provided written informed consent. Subjects should be cooperative, willing and able to participate and adhere to the protocol requirements.
- Have hematology, chemistry, kidney and liver function laboratory tests that are within (+/- 10%) of the current Mayo Clinic standardized normal values.
- Show a baseline EKG that demonstrates normal sinus rhythm and conduction without clinically significant abnormalities or arrhythmias.
- Are willing to return to research area for follow-up.
Exclusion Criteria:
- They show detectable pre-existing immunity to the AAV8 capsid as measured by AAV8 transduction inhibition and AAV8 total antibodies.
- Evidence of HIV or hepatitis of any etiology.
- Creatinine ≥ 1.5 mg/dL.
- Any disease or mental health condition at the physician's discretion that would prevent the subject from fully complying with the requirements of the study. The physician may exclude subjects with active alcohol abuse, other substance abuse or positive urine toxicology screen for substances of abuse.
- Pregnant &/or lactating. All lactating women will be excluded from study participation. Women of child-bearing potential must have a negative pregnancy test performed at screening visit, agree to use birth control throughout the study period, refrain from getting pregnant within the study period and consent to pregnancy testing throughout the study period. Men must agree to use barrier methods of birth control and refrain from fathering children within the next year.
- Morbid obesity (BMI > 40).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884594
Contact: Brenda Anderson, RN | (507) 255-7157 | Hooten.william@mayo.edu |
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | W. Michael Hooten, MD | Mayo Clinic |
Responsible Party: | W. Michael Hooten, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT04884594 |
Other Study ID Numbers: |
20-012225 5UH3DA042492 ( U.S. NIH Grant/Contract ) |
First Posted: | May 13, 2021 Key Record Dates |
Last Update Posted: | November 2, 2023 |
Last Verified: | October 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |