Evidence map›Paper›PMID 24793366›Full record

Trial reportDrug and alcohol dependence2014

Vaccine for cocaine dependence: a randomized double-blind placebo-controlled efficacy trial.

Thomas R Kosten, Coreen B Domingo, Daryl Shorter, Frank Orson, Charles Green, Eugene Somoza, Rachelle Sekerka, Frances R Levin, John J Mariani, Maxine Stitzer and 5 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 2 pooled it
9.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 2 syntheses or guidelines pooled it, 157 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. An antifentanyl monoclonal antibody reverses fentanyl-induced apnea in pigs.The Journal of pharmacology and experimental therapeutics · 2025
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Thomas R KostenMichael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe, Bldg. 121, Rm 141, Houston, TX 77030, United States. Electronic address: Kosten@bcm.edu.
Coreen B DomingoMichael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe, Bldg. 121, Rm 141, Houston, TX 77030, United States.
Daryl ShorterMichael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe, Bldg. 121, Rm 141, Houston, TX 77030, United States.
Frank OrsonMichael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe, Bldg. 121, Rm 141, Houston, TX 77030, United States.
Charles GreenUniversity of Texas, Houston, TX 77030, United States.
Eugene SomozaUniversity of Cincinnati, Cincinnati, OH, United States.
Rachelle SekerkaUniversity of Cincinnati, Cincinnati, OH, United States.
Frances R LevinColumbia University, New York, NY, United States.
John J MarianiColumbia University, New York, NY, United States.
Maxine StitzerJohns Hopkins University, Baltimore, MD, United States.
D Andrew TompkinsJohns Hopkins University, Baltimore, MD, United States.
John RotrosenNYU/VA NYHHS, New York, NY, United States.
Vatsal ThakkarNYU/VA NYHHS, New York, NY, United States.
Benjamin SmoakNYU/VA NYHHS, New York, NY, United States.
Kyle KampmanUniversity of Pennsylvania, Philadelphia, PA, United States.
Michael E. DeBakey VA Medical Center · USColumbia University · USJohns Hopkins University · USUniversity of Cincinnati · USVA NY Harbor Healthcare System · USBaylor College of Medicine · USNew York/New Jersey VA Health Care Network · USUniversity of Houston · USUniversity of Pennsylvania · US

Funding

HUMAN BEHAVIORAL PHARMACOLOGY OF SUBSTANCE ABUSET32DA007209 · NIDA · JOHNS HOPKINS UNIVERSITY · PI Eric C. Strain, Elise M Weerts · 1985 to 2026
$12.9M
Center for the Development of Novel Medications for Cocaine DependenceU54DA039002 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI KAMPMAN, KYLE MATTHEW · 2014 to 2018
$5.1M
1/2-Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine DependenceU01DA033310 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI LEVIN, FRANCES RUDNICK · 2013 to 2015
$2.2M
Multisite Controlled Trial of Cocaine Vaccine (1of 6) Lead Site/ Houston TreatmenR01DA025223 · NIDA · BAYLOR COLLEGE OF MEDICINE · PI KOSTEN, THOMAS RICHARD · 2008 to 2012
$1.7M
Multisite Controlled Trial of Cocaine Vaccine (4 of 6) Philadelphia Treatment SitR01DA025246 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI KAMPMAN, KYLE MATTHEW · 2008 to 2012
$1.2M
Multisite Controlled Trial of Cocaine Vaccine (5 of 6) New York University TreatmR01DA025248 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ROTROSEN, JOHN P · 2008 to 2012
$1.1M
Multisite Controlled Trial of Cocaine Vaccine (3 of 6) Baltimore Treatment SiteR01DA025251 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STITZER, MAXINE L · 2008 to 2012
$1.1M
Optimizing Pain Treatment while Reducing Abuse Liability in Opioid DependenceK23DA029609 · NIDA · JOHNS HOPKINS UNIVERSITY · PI TOMPKINS, DAVID ANDREW · 2012 to 2016
$929k
Multisite Controlled Trial of Cocaine Vaccine (2 of 6) Cincinnati Treatment SiteR01DA025249 · NIDA · UNIVERSITY OF CINCINNATI · PI SOMOZA, EUGENE C. · 2008 to 2012
$793k
NIDA NIH HHS K23 DA029609NIDA NIH HHS K23DA029609NIDA NIH HHS R01 DA025223NIDA NIH HHS R01DA025223NIDA NIH HHS R01 DA025246NIDA NIH HHS R01DA025246NIDA NIH HHS R01 DA 025248NIDA NIH HHS R01 DA025248NIDA NIH HHS R01 DA025249NIDA NIH HHS R01DA025249NIDA NIH HHS R01 DA025251NIDA NIH HHS R01DA025251NIDA NIH HHS R01 DA033310NIDA NIH HHS T32 DA007209NIDA NIH HHS T32DA007209NIDA NIH HHS U01 DA033310NIDA NIH HHS U54 DA039002
6 · The paper itself

Abstract

aimsWe evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.

methodsThis 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome.

resultsThe 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths.

conclusionsThe vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence.

Indexed as

AdolescentAdultAntibodiesCocaineCocaine-Related DisordersDouble-Blind MethodEthnicityFemaleHumansImmunotherapyMaleMiddle AgedSafetyTreatment OutcomeVaccinationVaccinesAntibodiesCocaineVaccinesClinical trialCocaineImmunotherapyVaccine

Identifiers

PMID24793366
PMCPMC4073297
OpenAlexW2025265305

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.