A Study to Evaluate AAV8-human Cocaine Hydrolase to Treat Cocaine Use Disorder

Overview

About this study

The purpose of this study is to see if an experimental agent, when given to subjects who wish to abstain from cocaine, will decrease their craving for cocaine and prevent them from relapsing and returning to cocaine use.  This experimental agent is called AAV8-hCocH; and it is a gene modified viral vector.  We want to determine the safety of its use in adults who have a cocaine use disorder in sustained remission.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 (BM > 40).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hooten, M.D.

Contact us for the latest status

Contact information:

William Hooten M.D.

(507) 266-3636

Hooten.William@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20514649

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