Who is eligible for clinical trial NCT04884594?

Participants must meet protocol criteria for Cocaine Dependence, in Remission. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04884594 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-21

AAV8-hCocH for Cocaine Use Disorder (NCT04884594)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: W. Michael Hooten

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (7 items).

Location: Mayo Clinic in Rochester — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mayo Clinic in Rochester — Rochester, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗