RECRUITING

AAV8-hCocH for Cocaine Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the safety of a novel gene viral vector treatment for adults with cocaine use disorder-sustained remission. This gene regulates an enzyme (cocaine hydrolase) that breaks down cocaine into inactive substances, thereby decreasing the pleasurable feeling this drug usually provides.

Official Title

Intravenous Administration of AAV8-human Cocaine Hydrolase to Treat Cocaine Use Disorder

Quick Facts

Study Start:2021-10-08

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04884594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Beth Martin, RRT

CONTACT

507-422-0647

Hooten.william@mayo.edu

Brenda Anderson, RN

CONTACT

507-255-7157

Hooten.williams@mayo.edu

Principal Investigator

W. Michael Hooten, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: W. Michael Hooten

W. Michael Hooten, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-08

Study Completion Date2026-12

Study Record Updates

Study Start Date2021-10-08

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Cocaine Dependence, in Remission