NCT00965263

Therapeutic Cocaine Vaccine: Human Laboratory Study

Tests of a Therapeutic Cocaine Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects. Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.

Detailed description

I do not desire to provide a more extensive description.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
BIOLOGICAL	Cocaine vaccine (TA-CD)	TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.

Timeline

• Start date: 2003-03-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2009-08-25
• Last updated: 2017-12-11
• Results posted: 2017-12-11

Locations

1 site across 1 country: United States