Health TrialsbyHealthPanel

Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

ConditionCocaine Dependence
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-69
SponsorWeill Medical College of Cornell University

About this trial

The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to treat the neurological effects of cocaine by evoking "immunity" to prevent the effects of cocaine on the brain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

All subjects should be able to provide informed consent.

Must provide HIV informed consent.

Males and females, 21- 69 years of age.

Individuals that have been diagnosed with a cocaine use disorder according to DSM-V-TR criteria, with documented evidence of cocaine use within the past 60 days and have previously used an average of 1 to 10 grams of powdered and/or crack cocaine (via insufflation or smoking only) per week. Any prior 1 to 4 month period of cocaine abstinence in the past year will be excluded when calculating average cocaine use to evaluate study eligibility.

Trial design

Design model

Sequential

Treatments tested in this trial

  • dAd5GNE Vaccine

    Biological/Vaccine

    dAd5GNE Vaccine or Placebo dAd5GNE Vaccine

  • Placebo

    Biological/Vaccine

    dAd5GNE Vaccine or Placebo dAd5GNE Vaccine

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Cohort 1: 100µgOther 2 interventions
Group B: Cohort 2: 316 µgOther 2 interventions
Group C: Cohort 3: 1000µgOther 2 interventions

Trial outcomes

Primary outcomes

1

Safety of dAd5GNE vaccine

The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a general assessment.

Time frame
32 weeks
2

Safety of dAd5GNE vaccine

The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a blood test.

Time frame
32 weeks
3

Safety of dAd5GNE vaccine

The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis.

Time frame
32 weeks
4

Safety of dAd5GNE vaccine

The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes chest x-ray.

Time frame
32 weeks

Secondary outcomes

1

Urine cocaine metabolites

Urine will be tested for benzoylecgonine (BE). The accepted value for a positive urine cocaine is urine BE of ≥ 300 ng/mL.

Time frame
32 weeks
2

Anti-cocaine antibody levels over time

The primary endpoint is average cocaine titers (week 10 - week 22) \> 4.0 x 105 titer units.

Time frame
32 weeks

Other outcomes

1

For Information Only

Anti-cocaine antibody subtypes, affinity, and specificity

Time frame
32 weeks
2

For Information Only

Anti-Ad5 antibodies

Time frame
32 weeks
3

For Information Only

Cocaine craving self-report

Time frame
32 weeks
4

For Information Only

Timeline followback (TLFB) drug use calendar

Time frame
32 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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