Evidence map›Paper›PMID 21696894›Full record

Trial reportDrug and alcohol dependence2011

A double-blind, placebo-controlled assessment of the safety of potential interactions between intravenous cocaine, ethanol, and oral disulfiram.

John D Roache, Roberta Kahn, Thomas F Newton, Christopher L Wallace, William L Murff, Richard De La Garza, Oscar Rivera, Ann Anderson, Jurij Mojsiak, Ahmed Elkashef

Open access · greenAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 19% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Disulfiram for the treatment of cocaine dependence.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Effect of alcohol on blood pressure.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Assessment of safety, cardiovascular and subjective effects after intravenous cocaine and lofexidine.Progress in neuro-psychopharmacology & biological psychiatry · 2014
    Trial
  8. Trial
  9. Article
  10. 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

10 authors at 3 institutions in 1 country.

John D RoacheUniversity of Texas Health Science Center, San Antonio, TX 78229, USA. roache@uthscsa.edu
Roberta Kahn
Thomas F Newton
Christopher L Wallace
William L Murff
Richard De La Garza
Oscar Rivera
Ann Anderson
Jurij Mojsiak
Ahmed Elkashef
National Institutes of Health · USThe University of Texas Health Science Center at San Antonio · USUniversity of California, Los Angeles · US

Funding

ZDV &3TC NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFECTED INFANTS &M01RR000865 · NCRR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI WASHINGTON, ARNOLD E. · 1985 to 2011
$43.4M
ZOLEDRONATE VS AREDIA IN MULTIPLE MYELOMA/BREAST CANCER W /BONE DISORDERSM01RR001346 · NCRR · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI FERRER, ROBERT L · 1985 to 2008
$23.1M
CLINICAL TRIAL OPERATIONS-271998101N01DA098101 · NIDA · UNIVERSITY OF TEXAS HLTH SCI CTR SAN ANT · 1999 to 2003
$971k
NCRR NIH HHS M01-RR0865NCRR NIH HHS M01 RR 1346NIDA NIH HHS N01 DA098101NIDA NIH HHS N01DA-9-8101
6 · The paper itself

Abstract

backgroundA majority of cocaine addicts have a comorbid alcohol use disorder. Previous studies demonstrated efficacy of disulfiram in the treatment of cocaine dependence among patients with comorbid alcohol use disorder or opioid dependence. However, the cardiac risks of a disulfiram-ethanol reaction (DER) in individuals who drink, when coupled with the cardiac effects of cocaine, could result in significant toxicity or lethality due to the 3-way drug interaction.

aimsThis study examined the safety of combining cocaine (30 mg i.v.) and ethanol (0.4 g/kg i.v.) in disulfiram-treated (0, 250, and 500 mg/d, p.o.) cocaine-dependent research volunteers.

resultsThe results showed that disulfiram did not enhance the cardiovascular effects of cocaine and may have reduced the subjective high from cocaine. In contrast, ethanol produced adverse ECG changes including QTc prolongation and a DER consisting of hypotension, tachycardia, nausea, and flushing in disulfiram-treated subjects. The severity of the DER was related to disulfiram dose and the trial with 500 mg/d was stopped prematurely due to safety concerns. The DER-related hypotension and tachycardia seen with ethanol infusion alone in disulfiram-treated subjects, was not exacerbated when combined with cocaine. In fact, cocaine tended to counteract the ethanol-related hypotension though it did exacerbate the tachycardia in two of seven subjects.

conclusionsThough conclusions are limited by the moderate doses of cocaine, ethanol, and disulfiram tested, the data do suggest that the risks of the moderate use of cocaine and ethanol in individuals treated with moderate doses of disulfiram (≤ 250 mg/d) may not be as problematic as some may assume.

Indexed as

AdultAlcohol DeterrentsBlood PressureCentral Nervous System DepressantsCocaineCocaine-Related DisordersDisulfiramDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug InteractionsElectrocardiographyEthanolFemaleHeart RateHumansAlcohol DeterrentsCentral Nervous System DepressantsCocaineDisulfiramEthanolPlacebos

Identifiers

PMID21696894
PMCPMC3205249
OpenAlexW2166804453

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.