drugset / Trial / NCT00969878
Multisite Controlled Trial of Cocaine Vaccine
Phase 2
Completed
300 enrolled
Baylor College of Medicine
Celtic Pharma Development Services · collabColumbia University · collabJohns Hopkins University · collabNational Institute on Drug Abuse (NIDA) · collabUS Department of Veterans Affairs Cooperative Studies Program · collabUniversity of Cincinnati · collabUniversity of Pennsylvania · collabVA Maryland Health Care System · collabVA New York Harbor Healthcare System · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).
Timeline
- Start
- 2010-08
- Primary completion
- 2012-08
- Completion
- 2014-07
Outcome
Missed primary endpoint
paper Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), PMID 24793366 ↗
Publications
- Kosten TR, Domingo CB, Shorter D, Orson F, Green C, Somoza E, Sekerka R, Levin FR, Mariani JJ, Stitzer M, Tompkins DA, Rotrosen J, Thakkar V, Smoak B, Kampman K. Vaccine for cocaine dependence: a randomized double-blind placebo-controlled efficacy trial. Drug Alcohol Depend. 2014 Jul 1;140:42-7. doi: 10.1016/j.drugalcdep.2014.04.003. Epub 2014 Apr 16.
- Martell BA, Orson FM, Poling J, Mitchell E, Rossen RD, Gardner T, Kosten TR. Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry. 2009 Oct;66(10):1116-23. doi: 10.1001/archgenpsychiatry.2009.128.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TA-CD | Vaccine | 400 ug | Intramuscular |