A Phase 1 interventional study of AAV8-hCocH and AAV8-hCocH in Cocaine Dependence, in Remission, sponsored by W. Michael Hooten. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by W. Michael Hooten · Phase 1, Interventional, and Other
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.
This is a phase-I dose escalation clinical trial testing the safety and MTD of IV administration of AAV8-hCocH to subjects with a history of cocaine use disorder-sustained remission. Subjects who provide written informed consent, meet entry criteria, and do not have transduction inhibition to AAV8 (pre-existing AAV8 antibodies) will be eligible. Subjects will be enrolled sequentially every 2-3 months or longer between cohorts. Dose escalation may be initiated after a single subject has been safely dosed; maximum enzyme expression is anticipated at week 3-4. This escalation paradigm is intended to minimize the number of subjects exposed to sub-therapeutic doses. The starting dose is based on the expression and safety of AAV8-CocH in mice, rats and NHP, and previous human experience using AAV8-FVIII IV in hemophilia patients. The starting dose has a large safety margin (15-fold) from the NOAEL in NHP. Approximately 7 weeks after an injection, a decision to escalate to the next dose level will be made based on a review of safety parameters and CocH levels by the investigative team.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →This is the only study on the registry with W. Michael Hooten as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: AAV8-hCocH
Cohort 3: Participant receives one-time IV administration of medium dose 6e12vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
Drug: AAV8-hCocH
Cohort 2: Participant receives one-time IV administration of medium dose 4e12vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
Drug: AAV8-hCocH
2e12 vg/kg single infusion intravenous
6e12 vg/kg single infusion intravenous
4e12 vg/kg single infusion intravenous
Adverse Events
Number of participants with treatment-related adverse events
Time frame: 60 months
Change in enzyme expression profile
Serum level of AAV8-hCocH gene expression
Time frame: Baseline, 24 months
Maximum Observed Plasma Concentration (Cmax)
Cmax is measured as the peak concentration of AAV8 in the blood after intravenous infusion
Time frame: 24 months
Time of peak concentration (tmax)
The time to maximum plasma concentration of AAV8 in the blood after intravenous infusion
Time frame: 24 months
Half-Life (t1/2)
The time for plasma concentration of AAV8 in the blood to be reduced to exactly half of starting concentration
Time frame: 24 months
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the AAV8 serum concentration over time. Used to characterize drug absorption.
Time frame: 24 months
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Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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