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Virus Therapy

Gene Therapy for Cocaine Use Disorder

Phase 1
Recruiting
Led By W. Michael Hooten, MD
Research Sponsored by W. Michael Hooten
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Study Summary

This trial is testing a new gene treatment for cocaine addiction that may help people quit by reducing the pleasure they feel from the drug.

Who is the study for?
Adults aged 18-65 with a diagnosis of cocaine use disorder in remission can join this trial. They must be motivated to stay off cocaine, able to attend regular clinic visits, and have normal heart rhythms and general health. Pregnant or breastfeeding individuals, those with obesity (BMI > 40), immunity to AAV8 capsid, HIV/hepatitis, kidney issues (Creatinine ≥ 1.5 mg/dL), or other disqualifying conditions cannot participate.Check my eligibility
What is being tested?
The trial is testing a new gene therapy using AAV8-hCocH for adults who are not seeking treatment but want to maintain their remission from cocaine use. This gene helps break down cocaine quickly which may reduce its pleasurable effects.See study design
What are the potential side effects?
Potential side effects aren't specified here but could include immune reactions due to the viral vector used in the gene therapy or other unforeseen responses related to altering enzyme levels that affect how the body processes cocaine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Change in enzyme expression profile
Secondary outcome measures
Area under the Concentration-Time Curve (AUC)
Half-Life (t1/2)
Maximum Observed Plasma Concentration (Cmax)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: AAV8-hCocH Medium dose: 6e12vg/kgExperimental Treatment1 Intervention
Cohort 2: Participant receives one-time IV administration of medium dose 6e12vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
Group II: AAV8-hCocH Low dose: 2e12 vg/kgExperimental Treatment1 Intervention
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
Group III: AAV8-hCocH High dose: 2e13 vg/kgExperimental Treatment1 Intervention
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

W. Michael HootenLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,399 Total Patients Enrolled
W. Michael Hooten, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
1,796 Total Patients Enrolled

Media Library

AAV8-hCocH (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04884594 — Phase 1
Cocaine Dependence Research Study Groups: AAV8-hCocH High dose: 2e13 vg/kg, AAV8-hCocH Low dose: 2e12 vg/kg, AAV8-hCocH Medium dose: 6e12vg/kg
Cocaine Dependence Clinical Trial 2023: AAV8-hCocH Highlights & Side Effects. Trial Name: NCT04884594 — Phase 1
AAV8-hCocH (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884594 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to partake in this experimental procedure?

"Affirmative. Clinicaltrials.gov has recorded evidence that this clinical trial, initially posted on October 8th 2021, is currently seeking participants. 10 volunteers are required to participate at one medical facility."

Answered by AI

What potential risks exist in administering AAV8-hCocH to individuals?

"There is limited data surrounding AAV8-hCocH's safety and efficacy, so it was assigned a score of 1."

Answered by AI

Is the cutoff age for inclusion in this study below 55 years old?

"This research study is seeking individuals over the age of consent and under 65 years old."

Answered by AI

What is the objective of this clinical research endeavor?

"The primary outcome measured over a 24 month period is Adverse Events. Meanwhile, secondary outcomes such as Time of peak concentration (tmax), Area under the Concentration-Time Curve (AUC) and Maximum Observed Plasma Concentration (Cmax) will be tracked to shed light on drug absorption."

Answered by AI

Is it possible to enlist in this medical research endeavor?

"In order to be eligible, contenders must have a history of cocaine dependence and fall within the specified age range. The trial is accepting up to 10 participants."

Answered by AI

How many individuals are involved in this experimental endeavor?

"Affirmative. The resources on clinicaltrials.gov indicate that this research is currently seeking participants, having initially been published on October 8th 2021 and last revised on 10/16/2022. At present, the study is in need of 10 volunteers at one site."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
AAV8-hCocH for Cocaine Use Disorder
W. Michael Hooten 2021. "AAV8-hCocH for Cocaine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884594.
~5 spots leftby Dec 2026
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