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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
Must not have
Morbid obesity (BMI > 40)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment that uses a virus to deliver a gene helping to break down cocaine. It targets adults who have had cocaine use disorder but are currently in remission. The treatment works by producing an enzyme that reduces the pleasurable effects of cocaine.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My BMI is over 40.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Change in enzyme expression profile
Secondary study objectives
Area under the Concentration-Time Curve (AUC)
Half-Life (t1/2)
Maximum Observed Plasma Concentration (Cmax)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: AAV8-hCocH dose level 3: 6e12vg/kgExperimental Treatment1 Intervention
Cohort 3: 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 dose level 2: 4e12vg/kgExperimental Treatment1 Intervention
Cohort 2: Participant receives one-time IV administration of medium dose 4e12vg/kg of AAV8-hCocH, with 7 week of follow-up after dose
Group III: AAV8-hCocH dose level 1: 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cocaine dependence include behavioral therapies, pharmacological interventions, and emerging gene therapies. The gene viral vector treatment, which regulates cocaine hydrolase, works by breaking down cocaine into inactive substances, thereby diminishing its pleasurable effects and reducing cravings.
This is particularly important for patients as it directly targets the biochemical pathway of addiction, potentially lowering the risk of relapse. Other treatments, such as cognitive-behavioral therapy and contingency management, focus on modifying behavior and reinforcing positive actions, while pharmacological options like disulfiram and topiramate aim to reduce cravings and withdrawal symptoms.
Together, these treatments offer a multifaceted approach to managing cocaine dependence.
The Development and Characterization of an scFv-Fc Fusion-Based Gene Therapy to Reduce the Psychostimulant Effects of Methamphetamine Abuse.Preclinical studies on neurobehavioral and neuromuscular effects of cocaine hydrolase gene therapy in mice.Intrastriatal gene delivery of GDNF persistently attenuates methamphetamine self-administration and relapse in mice.
The Development and Characterization of an scFv-Fc Fusion-Based Gene Therapy to Reduce the Psychostimulant Effects of Methamphetamine Abuse.Preclinical studies on neurobehavioral and neuromuscular effects of cocaine hydrolase gene therapy in mice.Intrastriatal gene delivery of GDNF persistently attenuates methamphetamine self-administration and relapse in mice.
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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
2,595 Previous Clinical Trials
3,328,733 Total Patients Enrolled
W. Michael Hooten, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
1,796 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old and not currently seeking treatment.I am not pregnant or breastfeeding and agree to use birth control during the study.My BMI is over 40.
Research Study Groups:
This trial has the following groups:- Group 1: AAV8-hCocH dose level 3: 6e12vg/kg
- Group 2: AAV8-hCocH dose level 2: 4e12vg/kg
- Group 3: AAV8-hCocH dose level 1: 2e12 vg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.