Evidence map›Paper›PMID 23414504›Full record

Trial reportThe American journal on addictions

Spontaneous development of IgM anti-cocaine antibodies in habitual cocaine users: effect on IgG antibody responses to a cocaine cholera toxin B conjugate vaccine.

Frank M Orson, Roger D Rossen, Xiaoyun Shen, Angel Y Lopez, Yan Wu, Thomas R Kosten

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal on addictions. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
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

17 citing papers in PubMed.

  1. Novel neurotherapeutic targets for substance use disorders: Neuroplasticity, neuroinflammation, gasotransmitters and non-canonical organ systems.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. The future potential for cocaine vaccines.Expert opinion on biological therapy · 2014
    Review
  14. Article
  15. New directions in nicotine vaccine design and use.Advances in pharmacology (San Diego, Calif.) · 2014
    Review
  16. Can you vaccinate against substance abuse?Expert opinion on biological therapy · 2013
    Review
  17. Review
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

6 authors.

Frank M OrsonMichael E. DeBakey VA Medical Center, Baylor College of Medicine, Houston, TX 77030, USA. forson@bcm.edu
Roger D Rossen
Xiaoyun Shen
Angel Y Lopez
Yan Wu
Thomas R Kosten

Funding

Human methamphetamine vaccine: Translational Avante Garde AwardDP1DA033502 · NIDA · BAYLOR COLLEGE OF MEDICINE · PI KOSTEN, THOMAS RICHARD · 2011 to 2015
$4.0M
GABAERGIC &GLUTAMATERGIC AGENTS--COCAINE USE IN METHADONE MAINTENANCEP50DA012762 · NIDA · YALE UNIVERSITY · PI KOSTEN, THOMAS RICHARD · 1999 to 2003
$3.8M
Cocaine Vaccine for Methadone Maintained PatientsR01DA015477 · NIDA · YALE UNIVERSITY · PI ROUNSAVILLE, BRUCE · 2002 to 2006
$1.7M
Development of Novel Vaccines for Cocaine AbuseR01DA030338 · NIDA · METHODIST HOSPITAL RESEARCH INSTITUTE · PI ORSON, FRANK M, WANG, RONGFU · 2010 to 2014
$1.6M
Developing Immunotherapeutics for Methamphetamine AbuseU01DA023898 · NIDA · BAYLOR COLLEGE OF MEDICINE · PI ORSON, FRANK M · 2009 to 2010
$1.4M
COMORBIDITY IN COCAINE AND OPIOID PHARMACOTHERAPYK05DA000454 · NIDA · YALE UNIVERSITY · PI KOSTEN, THOMAS RICHARD · 2000 to 2010
$1.3M
NIDA NIH HHS 1 R01 DA15477NIDA NIH HHS DA023898NIDA NIH HHS DA030338NIDA NIH HHS DP1 DA033502NIDA NIH HHS K05 DA000454NIDA NIH HHS K05‐DA 0454NIDA NIH HHS P50 DA012762NIDA NIH HHS P50-DA12762NIDA NIH HHS R01 DA015477NIDA NIH HHS R01 DA030338NIDA NIH HHS U01 DA023898
6 · The paper itself

Abstract

BACKGROUND AND

objectivesIn cocaine vaccine studies, only a minority of subjects made strong antibody responses. To investigate this issue, IgG and IgM antibody responses to cocaine and to cholera toxin B (CTB-the carrier protein used to enhance immune responses to cocaine) were measured in sera from the 55 actively vaccinated subjects in a Phase IIb randomized double-blind placebo-controlled trial (TA-CD 109).

methodsIsotype specific ELISAs were used to measure IgG and IgM anti-cocaine and anti-CTB antibody in serial samples collected prior to and at intervals after immunization. We assessed IgG anti-cocaine responses of patients with pre-vaccination IgM anti-cocaine antibodies. Competitive inhibition ELISA was used to evaluate antibody specificity. RESULTS AND

conclusionsBefore immunization, 36/55 subjects had detectable IgM antibodies to cocaine, and 9 had IgM levels above the 95% confidence limit of 11 μg/ml. These nine had significantly reduced peak IgG anti-cocaine responses at 16 weeks, and all were below the concentration (40 μg/ml) considered necessary to discourage recreational cocaine use. The IgG anti-CTB responses of these same subjects were also reduced. SCIENTIFIC SIGNIFICANCE: Subjects who develop an IgM antibody response to cocaine in the course of repeated recreational exposure to this drug are significantly less likely to produce high levels of IgG antibodies from the cocaine conjugate vaccine. The failure may be due to recreational cocaine exposure induction of a type 2 T-cell independent immune response. Such individuals will require improved vaccines and are poor candidates for the currently available vaccine.

Indexed as

Antibody SpecificityCholera ToxinCholera VaccinesCocaineCocaine-Related DisordersDouble-Blind MethodHumansImmunoglobulin GImmunoglobulin MCholera ToxinCholera VaccinesCocaineImmunoglobulin GImmunoglobulin M

Identifiers

PMID23414504
PMCPMC4143984

What OpenQuestion holds

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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.