What side effects are associated with this type of intervention?

Common treatments for cocaine dependence include behavioral therapies and pharmacological interventions. Behavioral therapies, such as cognitive-behavioral therapy (CBT), generally have minimal side effects but may include emotional distress as patients confront their addiction. Pharmacological treatments, such as disulfiram, topiramate, and modafinil, can have side effects including nausea, dizziness, and insomnia. For treatments similar to the gene viral vector treatment that regulates cocaine hydrolase, potential side effects could include immune reactions to the viral vector, insertional mutagenesis, and off-target effects, although specific data on these side effects are still under investigation.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically involving gene therapy or enzyme regulation, such as the gene viral vector treatment that regulates cocaine hydrolase, for cocaine dependence. Current FDA-approved treatments for cocaine dependence are limited, and most approaches focus on behavioral therapies and support groups rather than pharmacological interventions. Research is ongoing to find effective pharmacological treatments, including the novel gene viral vector treatment being studied to break down cocaine and reduce its pleasurable effects.

What other types of research exist?

Promising novel alternatives to gene viral vector treatment for cocaine dependence include: 1) Medications like N-acetylcysteine, which has shown potential in reducing cocaine cravings and relapse rates. 2) Behavioral therapies such as Cognitive Behavioral Therapy (CBT) and Contingency Management (CM), which have been effective in treating substance use disorders. 3) Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique that has shown promise in reducing cocaine use. 4) Vaccines targeting cocaine molecules to prevent them from reaching the brain, currently in clinical trials. These alternatives offer a range of approaches from pharmacological to behavioral and neurostimulation techniques.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

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 more

Awards & 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

0 / 1Eligibility criteria met

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.